FDA Approves Ramucirumab for Advanced Gastric or GEJ Cancer
On April 21, 2014, the U. S. Food and Drug Administration approved ramucirumab (Cyramza, Eli Lilly and Company) for use as a single agent for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior treatment with fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is a recombinant monoclonal antibody of the IgG1 class that binds to vascular endothelial growth factor receptor-2 (VEGFR-2) and blocks the activation of the receptor.
Read the FDA announcement here.
FDA Approves Ofatumumab in Combination with Chlorambucil, for Previously Untreated CLL
On April 17, 2014, the U. S. Food and Drug Administration approved ofatumumab (Arzerra Injection, for intravenous infusion; GlaxoSmithKline) in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate.
Read the FDA announcement here.
FDA Grants Orphan Drug Designation to Volasertib for AML
On April 17, 2014, Boehringer Ingelheim Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to volasertib for acute myeloid leukemia (AML). Volasertib is currently being evaluated in a Phase III clinical trial for the treatment of patients aged 65 or older, with previously untreated AML, who are ineligible for intensive remission induction therapy. Volasertib has not been approved by the FDA; its safety and efficacy have not been established.
In the U.S. Orphan Drug Designation is a status given to investigational compounds intended to treat a rare disease or condition that has limited treatment options. To qualify for FDA’s Orphan Drug Designation, the drug must, among other requirements, address a disease that affects fewer than 200,000 total people in the U.S.
Read company press release here.
NCI GEM Initiative Webinar on April 17
The National Cancer Institute's Grid Enabled Measures (GEM) initiative is presenting a webinar on GEM Care Planning: Advancing Survivorship Care Planning Through Community Engagement on Thursday, April 17, 2014, 2-3PM EST.
NCI's Carly Perry, PhD, MA, MSW, and University of Pittsburgh's Ellen Beckjord, PhD, MPH, will present on the GEM-Care planning (GEM-CP) initiative and related science. They will share insights into the GEM-CP platform and movement to develop consensus on measures to evaluate survivorship care planning as well as discuss results of the initiative. Learn more about GEM here: www.gem-measures.org.
To access the webinar online, go to https://webmeeting.nih.gov/gems and log in as a Guest at 1:45 pm. When the login screen appears, select the option to Enter as a Guest, enter your full name and click on the Enter Room button. Once you have entered the Adobe Connect Webmeeting, call the teleconference call number and follow the prompts:
Teleconference Number: 1-866-398-2885
Teleconference Passcode: 6381864930
ASCO Releases Three Guidelines on Survivorship Care
On April 14, the American Society of Clinical Oncology (ASCO) issued three evidence-based clinical practice guidelines on the prevention and management of symptoms that affect many cancer survivors—neuropathy, fatigue and depression, and anxiety. The guidelines are the first three in a planned series of guidelines on survivorship care.
Learn more here.
NCI Statement Outlines Changes in Clinical Trials Programs
The National Cancer Institute (NCI) issued a statement on April 4 that briefly outlines the changes now being made in the enterprises that conduct clinical trials under the auspices of the NCI. This includes creation of the new National Clinical Trials Network (NCTN), and consolidation of NCI’s several existing community-based clinical trials programs into an NCI Community Oncology Research Program (NCORP).
Read the NCI statement here.
More information is available here.
PQRS and eRx Incentive Program Participation Grows, CMS Says
The Centers for Medicare & Medicaid Services (CMS) reports increased participation in the Medicare Physician Quality Reporting System (PQRS) and the Electronic Prescribing Incentive (eRx) Program between 2011 and 2012. On April 3, CMS released “The 2012 Physician Quality Reporting System (PQRS) and Electronic Prescribing (eRx) Incentive Program Experience Report.” The report finds:
- Participation in the PQRS program grew by 36 percent from 2011. Approximately 36 percent of the 1,201,363 professionals who were eligible to participate in 2012 participated in PQRS. The 2012 PQRS incentive payments totaled $167,815,193.
- PSQRS participation is highest among eligible professionals who see the most Medicare patients. While the overall PQRS participation rate is 36%, participation is at 53% among those who treat more than 200 Medicare beneficiaries a year.
- Participation in the eRx program increased by 22 percent from 2011. Approximately 44 percent of the 778,904 professionals who were eligible to participate in 2012 participated in the eRx program. The 2012 eRx incentive payments totaled $335,331,216.
Read the CMS press release and access the full report here.
Senate Passes 1-Year SGR Extension
On March 31 the U.S. Senate approved sustainable growth rate (SGR) "patch" legislation to extend current Medicare physician payment rates through March 15, 2015. The House had approved the legislation on March 27. President Obama is expected to sign the bill, Bloomberg BNA reports.
The legislation would also delay implementation of ICD-10 until Oct. 1, 2015.
Update on Doxil Supply
In a March 24, 2014, Dear Healthcare Professional letter, Janssen Products, LP, provides an update on the doxil supply.
CMS Issues Meaningful Use 2014 CEHRT Hardship Exception Guidance
On March 10, the Centers for Medicare & Medicaid Services (CMS) issued hardship exception guidance for Medicare-participating eligible providers (EPs) and eligible hospitals unable to implement the 2014 Edition of Certified Electronic Health Record (EHR) Technology in time to successfully demonstrate meaningful use for the 2014 reporting year.
The guidance is to help EPs and hospitals who participated in Stage 1 of the meaningful use program but have been unable to update their EHR systems this year to comply with the 2014 Edition EHR certification criteria from the Office of the National Coordinator of Health IT.
Payment adjustments based on the 2014 reporting period will go into effect in 2016. CMS notes that the payment adjustments only apply to the Medicare EHR Incentive Program.
CMS issued separate one-page guidance for Medicare-participating EPs and Medicare-participating hospitals.
Read the guidance for eligible professionals here.
In additional guidance for eligible professionals and eligible hospitals updated in March, CMS indicated that additional exceptions may be granted for other reasons such as being newly practicing EPs, practice at multiple locations, and “unforeseen circumstances.”
CMS Will Not Finalize Several Provisions of Part D Proposal
In a March 10 letter, the Centers for Medicare & Medicaid Services (CMS) Administrator Marilyn Tavenner told Congress the agency will not move ahead with four provisions of a Part D proposed rule, including the proposal to lift the "protected class" definition of three drug classes.
In the letter, Tavenner said: “Give the complexities of these issues and stakeholder input, we do not plan to finalize these proposals at this time.”
Read the letter here.
CMS Seeks Comments on Transforming Physician Payment Models
The Centers for Medicare & Medicaid Services (CMS) is seeking comments on the best methods for assisting physician practices in the move from a fee-for-service reimbursement model to alternative payment models. On March 5, CMS issued a request for information (RFI) on delivery system reform. The agency is asking for input on policy considerations about large scale transformation of clinical practices with the aim of better care and better health at lower costs. CMS may use the information collected from this RFI to test new payment and service delivery models.
The deadline for comments is April 8, 2014.
Administration’s Proposed FY 2015 Budget Includes $1 Trillion in Health Spending
On March 4 the Obama administration proposed a fiscal year (FY) 2015 budget that includes nearly $1 trillion for federal health programs administered by the Department of Health and Human Services (HHS). Included are legislative proposals for Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP) that the administration says will save more than $400 billion through 2024.
However, it is unlikely that the administration’s proposals in their current form will be passed by Congress. Many of the proposals have been included in previous budgets proposed by the administration and have not been acted upon.
The proposed FY 2015 budget includes the following Medicare-specific proposals:
- Increase premiums under Part B and Part D for higher income beneficiaries
- Reduce reimbursements for Part B drugs from 106 percent of average sales price to 103 percent
- Align Medicare drug payment policies with Medicaid policies for low-income beneficiaries
- Prohibit critical access hospital designation for facilities that are less than 10 miles from the nearest hospital
- Strengthen the Independent Payment Advisory Board (IPAB) for Medicare by lowering the target rate for triggering IPAB recommendations to Congress.
Read the Health and Human Services FY 2015 Budget in Brief here.
FDA Grants Accelerated Approval to Ibrutinib for CLL
On Feb. 12, 2014, the U. S. Food and Drug Administration (FDA) granted accelerated approval to ibrutinib (IMBRUVICA, Pharmacyclics, Inc.) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.
Ibrutinib previously received accelerated approval on November 13, 2013, for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
Sunshine Act Data Collection to Begin Feb. 18, CMS Says
The Centers for Medicare & Medicaid Services (CMS) has announced the agency will start the first phase of Sunshine Act data collection on Feb. 18, 2014. During the initial phase, some manufacturers and group purchasing organizations will start submitting data to CMS on payments made to healthcare providers, including gifts, consulting fees, and research activities. Phase two, which will begin in May, will include industry registration in the CMS Open Payments system, submission of detailed 2013 payment data, and legal attestation to the accuracy of the data, Bloomberg BNA reports.
CMS Extends Medicare EHR Attestation Deadline for EPs; Offers Hospitals Attestation Help
On Feb. 7, the Centers for Medicare & Medicaid Services (CMS) announced a one-month extension—from 11:59 pm on February 28 to 11:59 pm on March 31, 2014—of the deadline for physicians and other eligible professionals (EPs) to meet the requirements of Medicare Meaningful Use program in 2013.
The hospital deadline was Dec. 1, 2013. However, the agency said that hospitals that experienced problems in attesting in 2013 can retroactively submit their attestation data in 2014. Hospitals that want to retroactively submit 2013 data must contact CMS by March 15, 2014.
The one-month deadline extension applies only to the Medicare EHR Incentive Program and not to the Medicaid EHR Incentive Program or the Physician Quality Reporting System EHR Incentive Program, the agency said.
Zaltrap Issued Permanent J Code
The Centers for Medicare & Medicaid Services (CMS) has granted Zaltrap® (ziv-aflibercept) Injection for Intravenous Infusion a permanent J Code: J9400. This new HCPCS code is effective for dates of service on or after January 1, 2014.
HHS Agency Suspends New Medicare Appeals for 2 Years, Due to Backlog
A memorandum from the Department of Health and Human Services (HHS) Office of Medicare Hearings and Appeals (OMHA) states that it is suspending the assignment of new Medicare appeals to administrative law judges for at least two years in order to work through an increasing backlog of appeals, according to Bloomberg BNA Health Care Daily Report (01/16, 2014). However, new beneficiary-initiated appeals will not be suspended.
The memorandum, authored by OMHA’s Chief Administrative Law Judge Nancy J. Griswold, said the suspension was effective as of July 15, 2013, and will affect most Medicare appeals at the ALJ appeal level. Griswold said the suspension applied to “Medicare providers and suppliers, and Medicaid state agencies,” BNA reports.
However, the letter stated that appeals filed directly by Medicare beneficiaries will continue to be assigned and processed “to ensure [beneficiaries’] health and safety is protected.”
OMHA will hold an Medicare Appellant Forum in Washington on February 12 to address the impact of the appeals suspension.
HHS Report Provides Demographic Information on Insurance Marketplace Enrollees
From Oct. 1 to Dec. 28, 2013, almost 2.2 million people selected plans through the Affordable Care Act’s state and federal insurance Marketplaces, according to a report released Jan. 13, by the U.S. Department and Health and Human Services’ Office of the Assistant Secretary for Planning and Evaluation (ASPE). The report presents a “snapshot” of Marketplace enrollment-related activity during the initial open-enrollment period, based on available data. Highlights from the report include:
Marketplace Plan Selection by Age
- 24% of those who have selected a Marketplace plan are between the ages of 18 and 34.
- 30% of those who have selected a Marketplace plan are between the ages of 0 and 34.
Marketplace Plan Selection by Metal Level
- 60% of those selecting a Marketplace plan opted for a “Silver” tier plan.
- 20% have selected a Bronze tier plan.
- 13% have selected a Gold tier plan.
- 7% have selected a Platinum tier plan.
- 1% have selected a Catastrophic plan.
Marketplace Plan Selection by Financial Assistance
- 79% of those who have selected a Marketplace plan have selected a plan with financial assistance.
The report includes state-by-state information.
FDA Approves Mekinist in Combination with Tafinlar for Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has approved Mekinist® (trametinib) for use in combination with Tafinlar® (dabrafenib) for the treatment of patients with unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutations. These mutations must be detected by an FDA-approved test. Tafinlar is not indicated for treatment of patients with wild-type BRAF melanoma.
The FDA approved the combination of Mekinist and Tafinlar under the agency’s accelerated approval program.
USPSTF Releases Final Recommendation on Screening for Those at High Risk of Lung Cancer
On Dec. 30, 2013, the U.S. Preventive Services Task Force (USPSTF) released its final recommendation on screening those at high risk of lung cancer, grading annual low-dose CT screening for individuals at high risk for lung cancer with a B grade.
The USPSTF recommends annual screening for lung cancer with low-dose computed tomography (LDCT) in adults aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery.
USPSTF Finds Benefit in Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-related Cancer for Small Group of High-Risk Women
On Dec. 24, 2013, the U.S. Preventive Services Task Force (USPSTF) issued its final recommendation on risk assessment, genetic counseling, and genetic testing for BRCA-related cancer in women. The USPSTF recommends that women with family members who have had breast, ovarian, tubal, or peritoneal cancer talk with a healthcare professional to learn if their history might put them at risk for carrying a BRCA mutation. Women who screen positive should receive genetic counseling and, if indicated after counseling, BRCA testing. Additionally, for the vast majority of American women (90 percent), who do not have a family history associated with an increased risk for the inherited mutations, the USPSTF continues to recommend against genetic counseling and testing.
CMS Announces 123 New Provider Groups to Participate in MSSP as ACOs
On December 23, 2013, the Centers for Medicare & Medicaid Services (CMS) announced 123 new provider groups that will be participating in the Medicare Shared Savings Program (MSSP) in 2014 as accountable care organizations (ACOs), Bloomberg BNA reports.
The agency said that the new ACOs represent a diverse cross-section of healthcare providers, including those providing care in underserved areas. According to CMS, the new ACOs will deliver care for about 1.5 million more Medicare beneficiaries. The performance period for the new ACOs starts Jan. 1, 2014.
Annual Report to the Nation Shows Lung Cancer Deaths Continue to Decline
The Annual Report to the Nation on the Status of Cancer, covering the period 1975–2010, showed death rates for lung cancer, which accounts for more than one in four cancer deaths, dropping at a faster pace than in previous years. The recent larger drop in lung cancer deaths is likely the result of decreased cigarette smoking prevalence over many years, and is now being reflected in mortality trends. The report showed, however, that death rates increased for some cancers, including cancers of the liver and pancreas for both sexes, cancers of the uterus in women, and, in men only, melanoma of the skin and cancers of the soft tissue in this 10 year period.
The Report, produced annually since 1998, is co-authored by researchers from the National Cancer Institute (NCI); the American Cancer Society (ACS); the Centers for Disease Control and Prevention (CDC); and the North American Association of Central Cancer Registries (NAACCR). The Report appeared online in the journal Cancer on Dec. 16, 2013.
The Annual Report to the Nation on the Status of Cancer, 1975-2010, Featuring Prevalence of Comorbidity and Impact on Survival Among Persons With Lung, Colorectal, Breast, or Prostate Cancer is available here.
Federal Pre-Existing Condition Insurance Plan Extended One Month
The federal government’s Pre-Existing Condition Insurance Plan (PCIP), which was set to expire on Dec. 31, 2013, will be extended for one month while the government works to fix the Affordable Care Act health exchange that is intended to serve as an alternative, according to Bloomberg BNA Health Care Daily Report (Dec. 13, 2013). Individuals in the program who have not obtained coverage will be able to stay through the end of January, Aaron Albright, a CMS spokesperson said in a Dec. 12 email, BNA reports.
The extension does not affect high-risk insurance pools for sick people independently run by 35 states. Expiration dates for those plans vary and, in some states, will extend beyond Jan. 1, BNA reports.
CMS Delays Start of Stage 3 Meaningful Use
On Dec. 6, 2013, the Centers for Medicare & Medicaid Services (CMS) announced it will delay the start of Stage 3 Meaningful Use for one year, according to Bloomberg BNA Health Care Daily Report. Under the revised timeline, Stage 2 will be extended through 2016 and Stage 3 will begin in 2017 for those providers that have completed at least two years in Stage 2.
Hospitals and providers who have received incentive payments for at least two years under Stage 1 of the Meaningful Use program will still be required to move into Stage 2 in 2014. But the delay will provide an additional year of reporting under Stage 2 before they must move to Stage 3.
The revised timeline will not affect the 2016 Medicare payment penalties scheduled for providers and hospitals that do not meet meaningful use requirements, a CMS spokesperson told BNA.
CMS Releases 2014 PFS Final Rule
On Nov. 27, 2013, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2014 Physician Fee Schedule (PFS) final rule. Among the provisions included in the 2014 PFS final rule are the following:
Primary Care and Chronic Care Management. Medicare will begin making a separate payment for chronic care management services beginning in 2015. The rule indicates that CMS intends to establish practice standards necessary to support payment for furnishing care management services through future notice-and-comment rulemaking.
Misvalued Codes. Consistent with amendments made by the Affordable Care Act, CMS has been engaged in a vigorous effort over the past several years to identify and review potentially misvalued codes, and make adjustments where appropriate. The agency is continuing this effort as the values for around 200 codes were finalized and approximately 200 additional codes had their work relative value units changed on an interim basis for 2014.
CMS is not finalizing its proposal to adjust relative values under the PFS to effectively cap the physician practice expense payment for procedures furnished in a non-facility setting at the total payment rate for the service when furnished in an ambulatory surgical center or hospital outpatient setting. Instead, CMS will take additional time to consider issues raised by the public commenters and plans to address this issue in future rulemaking.
Compliance with State Law for “Incident To” Services. CMS is requiring as a condition of Medicare payment that “incident to” services be furnished in compliance with applicable state law. CMS also eliminated redundant regulations for each type of practitioner by consolidating the “incident to” requirements for all practitioners that are permitted to bill Medicare directly for their services, reducing the regulatory burden and making it less difficult for practitioners to determine what is required in order to bill Medicare for “incident to” services.
ACCC is continuing to review the final 2014 PFS rule and will have a more complete summary available later this week. ACCC will also host a members-only conference call on the 2014 OPPS and PFS final rules on Thursday, December 12.
The 2014 PFS final rule will appear in the December 10 Federal Register.
CMS Releases 2014 OPPS Final Rule
On Nov. 27, 2013, the Centers for Medicare & Medicaid Services (CMS) released the final calendar year (CY) 2014 Hospital Outpatient Prospective Payment System (OPPS) rule. The final rule updates the OPPS market basket by 1.7 percent for CY 2014.
Under the final rule, changes to hospitals OPPS payments and policies include:
Items and Services to be “Packaged” or Included in Payment for a Primary Service. For 2014, CMS finalizes five new categories of supporting items and services rather than the seven proposed. For certain cases, a separate payment would be made if the item or service is furnished on a different date of service as the primary service. The five final categories are:
1) Drugs, biologicals, and radiopharmaceuticals that function as supplies when used in a diagnostic test or procedure;
2) Drugs and biologicals that function as supplies; when used in a surgical procedure, including skin substitutes. Skin substitutes will be classified as either high cost or low cost and will be packaged into the associated surgical procedures with other skin substitutes of the same class;
3) Certain clinical diagnostic laboratory tests;
4) Certain procedures described by add-on codes;
5) Device removal procedures.
In addition to packaging these five categories, CMS finalizes its proposal to create 29 comprehensive APCs to replace 29 existing device-dependent APCs, but with a modification to apply a complexity adjustment for the most complex multiple device claims. CMS is delaying the implementation of these comprehensive APCs until CY 2015.
Collapsing Five Levels of Visits to One. The final rule streamlines the current five levels of outpatient clinic visit codes, replacing them with a single Healthcare Common Procedure Coding System (HCPCS) code describing all clinic visits.
The final rule does not finalize the proposal to replace the current five levels of codes for each type of emergency department visits. CMS intends to consider options to improve the codes for these services in future rulemaking.
Part B Drugs in the Outpatient Department. The rule finalizes the proposal to continue paying at ASP+6 percent for non-pass-through drugs and biologicals that are payable separately under the OPPS.
ACCC is continuing to review the final 2014 OPPS rule and will have a more complete summary available later this week. ACCC will also host a members-only conference call on the 2014 OPPS and PFS final rules on Thursday, December 12.
The 2014 OPPS final rule will appear in the December 10 Federal Register, and can be viewed here.
FDA Approves Nexavar to Treat Metastatic Differentiated Thyroid Cancer
On Nov. 22, 2013, the U.S. Food and Drug Administration (FDA) expanded the approved uses of Nexavar (sorafenib) to treat late-stage (metastatic) differentiated thyroid cancer. Differentiated thyroid cancer is the most common type of thyroid cancer.
Nexavar works by inhibiting multiple proteins in cancer cells, limiting cancer cell growth and division. The drug’s new use is intended for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that no longer responds to radioactive iodine treatment.
The FDA approved Nexavar to treat advanced kidney cancer in 2005. In 2007, the agency expanded the drug’s label to treat liver cancer that cannot be surgically removed.
Commission on Cancer to Modify Standard 1.3
The Accreditation Committee of the American College of Surgeons Commission on Cancer (CoC) has approved a motion to modify Standard 1.3, Cancer Committee Attendance. The modification will allow for an appointed individual and one designated alternate for both physician and non-physician members of the Cancer Committee. The individual appointment and alternate designation would be set at the beginning of the year when membership is confirmed. The revision to the standard would allow for the attendance of the appointed individual and the designated alternate to be combined to meet the percentage attendance requirement.
The CoC’s Standards Advisory Group of Excellence (SAGE) recommended that the Accreditation Committee approve the changes which will be implemented Jan. 1, 2014.
PCORI Board Approves More than $1 Billion in Funding for CER
The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors recently approved a two-year commitment to spend more than $1 billion in funding for comparative effective research (CER) projects in fiscal years 2014 and 2015, Bloomberg BNA Health Care Daily reports. At a November 18 meeting, the PCORI board also accepted the revised version of its methodology report that sets the groundwork for standards and types of research methods that can be used to develop CER.
PCORI has also adopted a new strategic plan that outlines three goals to advance patient-centered outcomes research: These are:
- To substantially increase the quantity, quality, and timeliness of useful, reliable evidence to improve healthcare decision making;
- To speed the implementation and use of findings from patient-centered outcomes research; and
- To influence clinical and healthcare research funded by others to be more patient-centered.
FDA Grants Crizotinib Regular Approval for Metastatic NSCLC
On November 20, 2013, the U. S. Food and Drug Administration (FDA) granted regular approval for crizotinib (Xalkori) capsules for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
The approval was based on demonstration of superior progression-free survival (PFS) and overall response rate (ORR) for crizotinib-treated patients compared to chemotherapy in patients with ALK-positive NSCLC with disease progression after platinum-based doublet chemotherapy.
An open-label, active-controlled, multinational, randomized trial enrolled 347 patients with ALK-positive, metastatic NSCLC. Patients were required to have progressed following platinum-based chemotherapy and to have ALK expression in tumor specimens detected by fluorescence in situ hybridization on central laboratory testing. Patients were randomized to receive either crizotinib 250 mg orally twice daily (n=173) or chemotherapy (n=174). Patients randomized to chemotherapy received pemetrexed (58%) or docetaxel (42%) if they had received prior pemetrexed. Approximately 64% of patients on the chemotherapy arm subsequently received crizotinib.
The trial demonstrated significantly prolonged progression-free survival (PFS) for crizotinib treatment compared to chemotherapy [HR=0.49, (95% CI: 0.37, 0.64), p<0.0001].
Crizotinib was previously granted accelerated approval in August 2011, based on durable, objective response rates (ORR) of 50% and 61% in two single-arm, open-label studies.
FDA Approves Imbruvica for Mantle Cell Lymphoma (MCL)
On Nov. 13, 2013, the U.S. Food and Drug Administration approved Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer.
MCL is a rare form of non-Hodgkin lymphoma and represents about 6 percent of all non-Hodgkin lymphoma cases in the U.S. By the time MCL is diagnosed, it usually has already spread to the lymph nodes, bone marrow, and other organs.
Imbruvica is intended for patients with MCL who have received at least one prior therapy. It works by inhibiting the enzyme needed by the cancer to multiply and spread. Imbruvica is the third drug approved to treat MCL. Velcade (2006) and Revlimid (2013) are also approved to treat the disease.
Imbruvica is the second drug with breakthrough therapy designation to receive FDA approval. The Food and Drug Administration Safety and Innovation Act, passed in July 2012, gave the FDA the ability to designate a drug a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases.
FDA Approves Gazyva (obinutuzumab) for CLL
On November 1, 2013, the U.S. Food and Drug Administration (FDA) approved obinutuzumab (Gazyva™ injection, for intravenous use, previously known as GA101) for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
Obinutuzumab is approved with a BOXED WARNING regarding Hepatitis B virus reactivation and Progressive Multifocal Leukoencephalopathy. Patients should be advised of these risks and assessed for Hepatitis B virus and reactivation risk. Infusion reactions are included in the WARNING and PRECAUTIONS section of the label.
Read the FDA press release here.