FDA Issues EAU for Monoclonal Antibody to Treat COVID-19

• Have positive results of direct SARS-CoV-2 viral testing
• Are 12-years-old or older
• Weigh at least 40 kilograms (about 88 pounds)
• Are at high risk for progressing to severe COVID-19 and/or hospitalization.

Bamlanivimab has shown through clinical trials to reduce COVID-19-related hospitalizations or emergency room visits in patients at high risk for disease progression within 28 days after treatment, compared to placebo. As part of the EUA, efficacy of the agent continues to be evaluated and several quality measures have been imposed to protect patients. 

Read the FDA announcement. 

Posted 11/20/2020

CMS to Release Permanent J-Code for Phesgo™ Injection

Pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo™, Genentech) injection for subcutaneous use will be issued a permanent J-Code that can be used starting January 1, 2021.

This single code (J9316) is to be used for all PHESGO patients and dosage strengths. 

Indications

Early Breast Cancer 
Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is indicated for use in combination with chemotherapy for

• The neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer (EBC); and

• The adjuvant treatment of adult patients with HER2-positive early breast cancer (EBC) at high risk of recurrence.

Select patients for therapy based on an FDA-approved companion diagnostic test.

Metastatic Breast Cancer  
Phesgo™ is indicated for use in combination with docetaxel for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Select patients for therapy based on an FDA-approved companion diagnostic test.

See prescribing information.

Posted on 11/19/2020

FDA Approves Pembrolizumab + Chemotherapy for TNBC

Registration Open: Jakafi (ruxolitinib) Product Theater

Intervening With Jakafi^® (ruxolitinib) to Achieve Durable Count Control: Real-World Patient Case Discussion 

Jakafi^® (ruxolitinib) is indicated for the treatment of patients with polycythemia vera who have had an inadequate response to—or are intolerant of—hydroxyurea; patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF; and for the  treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.

Join a one-hour live presentation—sponsored by Incyte Corporation—to learn more about the use of Jakafi^® (ruxolitinib) in treating your patients. 

Monday, November 30
12:00 - 1:00 PM EST

Presented by:
Solomon Hamburg, MD, PhD
Clinical Professor of Medicine, Division of Hematology-Oncology, Department of Medicine
UCLA Beverly Hills Hematology Oncology
REGISTER

Monday, November 30
3:00 - 4:00 PM EST

Presented by:
Jonathan Abbas, MD
Director, Acute Leukemia Program
Tennessee Oncology
REGISTER

FDA Accepts for Priority Review Cemiplimab-rwlc for Advanced NSCLC

On Thursday, October 29, the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor cemiplimab-rwlc (Libtayo^®, Regeneron Pharmaceuticals, Inc.) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression.

The target action date for the FDA decision is February 28, 2021.

Read press release. 

Posted on 10/29/2020.

FDA Approves Expanded Indication of Pembrolizumab for R/R cHL

Ibrutinib for the Treatment of Adult Patients with CLL/SLL

Read efficacy study and prescribing information. 

To help guide and assist patients during treatment, Pharmacyclics the YOU&i^TM Support Program, which provides information on insurance coverage and out-of-pocket costs, and what to expect while on treatment.

Posted on 10/07/2020

myBeiGene Patient Support for Zanubrutinib

Zanubrutinib (Brukinsa™, BeiGene) is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. For prescribing information click here, or here for the Dosing and Administration Guide. 

To help guide and assist patients during treatment, Beigene has developed a customized and comprehensive support program. The myBeiGene Patient Support program is staffed with nurses who have prior experience working with oncology patients. Practices and their patients get a dedicated Oncology Nurse Advocate assigned to them, and comprehensive patient support, including connecting patients to helpful resources that can address their personal needs.

Posted on 10/07/2020

Exelixis Access Services® EASE

Exelixis Access Services^® (EASE) provides a variety of support to help your patients get started on cabozantinib (Cabometyx^®)as soon as possible. EASE can help meet the unique needs of your patients and practice at each step along the access journey. 

Posted 10/02/2020

Cabozantinib Prescribing Information and Resources

Exelixis has issued prescribing information for cabozantinib (Cabometyx^®), which is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) and patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib as well as a series of resources that you can utilize in your practice. 

Access Prescribing Information and Resources.

Posted 10/02/2020

FDA Approves Nivolumab + Ipilimumab Immunotherapy Treatment for Mesothelioma

On October 2, 2020 the U.S. Food and Drug Administration (FDA) approved the combination of Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a first-line treatment for adult patients with unresectable malignant pleural mesothelioma.

Read the FDA Announcement.

Read the Bristol Myers Squibb Announcement.

Posted 10/5/2020 

FDA Approves Two Liquid Biopsy Companion Diagnostics for Osimertinib

On August 7, the U.S. Food and Drug Administration (FDA) approved FoundationOne^® Liquid CDx and Guardant360^® CDx as next generation sequencing based liquid biopsy companion diagnostics for osimertinib (Tagrisso^®) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test; and for patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

See full prescribing information.

About FoundationOne^® Liquid CDx.

About Guardant360^® CDx.

Posted 9/24/2020

CMS Releases RO Model Final Rule

On Friday, September 18, 2020 the Centers for Medicare & Medicaid Services (CMS) released the final rule for the Radiation Oncology (RO) Model. The RO Model seeks to improve the quality of care for cancer patients receiving radiotherapy (RT) and move toward a simplified and predictable payment system. The RO Model tests whether bundled, prospective, site neutral, modality agnostic, episode-based payments to physician group practices, hospital outpatient departments, and freestanding radiation therapy centers for RT episodes of care reduces Medicare expenditures while preserving or enhancing the quality of care for Medicare beneficiaries. The RO Model has a five-year Model performance period that begins on January 1, 2021 and runs through December 31, 2025.

For additional information on the final rule and the model, please visit the radiation oncology website. The following resource documents about RO may also be helpful: Press Release, Fact Sheet, and Final Rule. For questions regarding the RO Model, please reach out to the RO Model Helpdesk by phone: 1.844.711.2664, option 5; or email: RadiationTherapy@cms.hhs.gov.

Posted 9/18/2020

Lilly Announces Thyroid Cancer Testing Program

Lilly announces their Thyroid Cancer Testing Program designed to provide access to molecular testing for appropriate advanced or metastatic medullary thyroid cancer (“MTC”) patients 12 years of age and older who require systemic therapy; and advanced or metastatic non-medullary thyroid cancer (“non-MTC”) patients 12 years of age and older who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Appropriate patients are eligible for one molecular test at no cost for the purpose of determining whether the patient has any actionable genetic alterations that may inform therapeutic decisions, without regard to purchase of any prescribed drug or any other product.*

No patient, healthcare program, payer, or beneficiary shall be billed for any test ordered pursuant to the Thyroid Cancer Testing Program.

Posted 9/16/2020

To request a test for your patient <and understand further requirements>, you may download the Thyroid Cancer Testing Program Test Request Form.

The Thyroid Cancer Testing Program is NOT available to New York State patients and facilities as the aforementioned NGS tests have not been approved by the New York State Department of Health.

Posted 9/16/2020

CMS Issues FY2021 IPPS and LTCH Final Rule

On September 2, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) final rule, which includes important provisions designed to ensure access to potentially life-saving diagnostics and therapies for hospitalized Medicare beneficiaries. The changes will affect approximately 3,200 acute care hospitals and approximately 360 Long-Term Care Hospitals. CMS estimates that total Medicare spending on acute care inpatient hospital services will increase by about $3.5 billion in FY 2021, or 2.7 percent. 

CMS’ rule creates a new Medicare Severity Diagnostic Related Group (MS-DRG) that provides a predictable payment to help adequately compensate hospitals for administering Chimeric Antigen Receptor (CAR) T-cell therapies.

Also in the final rule, CMS approved a record number of 24 new technology add-on payments, which is an additional payment to hospitals for cases involving eligible new and relatively high cost technologies. This will provide additional Medicare payment for these technologies while real-world evidence is emerging, giving Medicare beneficiaries timely access to the latest innovations.

Read the fact sheet and final rule from the Federal Register.

Posted 9/2/2020

FDA Approves Azacitidine for AML Continued Treatment

CMS Releases CY 2021 OPPS and PFS Proposed Rules

On August 4, 2020, the Centers for Medicare & Medicaid Reimbursement (CMS) issued the calendar year (CY) 2021 Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment Proposed Rule (CMS-1736-P). ACCC and council are reviewing these proposed rules and will be providing comments.

Until this analysis is complete, read the proposed OPPS rule and the proposed PFS rule. Then register for ACCC’s August 14 webcast on The 2021 Proposed PFS and OPPS Rules: Practical Implications and Considerations to gain insight into how these proposed rules will affect your cancer program.

Posted 8/6/2020

FDA Approves Tafasitamab-cxix + Lenalidomide for R/R DLBCL

On July 31, 2020 MorphoSys and Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.

Read corporate press release.

Read FDA announcement.

Posted 8/3/20

FDA Approves Keytruda for Patients with Unresectable or Metastatic MSI-H or dMMR CRC

On June 29, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

MSI-H/dMMR testing is required prior to initiating treatment with Keytruda in these patients. For the MSI-H/dMMR indication, select patients for treatment with Keytruda as a single agent based on MSI-H/dMMR status in tumor specimens. An FDA-approved test for the detection of MSI-H or dMMR is not currently available.

Read prescribing information and medication guide. 

Posted 7/17/2020

FDA Approves Pembrolizumab for Patients with Recurrent or Metastatic cSCC

On June 24, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co.) injection 100 mg for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. 

Read FDA announcement and prescribing information. 

Posted 7/14/2020