Industry News Archive

  • FDA Issues EUA for Casirivamab + Imdevimab Antibodies to Treat COVID-19

    On November 21, 2020, the U.S. Food and Drug Administration (FDA) announced its second emergency use authorization (EUA) for monoclonal antibodies to treat COVID-19. Under the EUA, casirivamab and imdevimab must be administered together by intravenous use for the treatment of mild to moderate COVID-19 in adults and pediatric patients who:

    • Are 12-years-old or older

    • Weigh at least 40 kilograms (about 88 pounds)

    • Have positive results of direct SARS-CoV-2 viral testing

    • Are at risk for progressing to severe COVID-19*.

    *This includes those who are 65 years of age or older or who have certain chronic medical conditions.

    When administered together in patients with COVID-19 via clinical trial, casirivamab and imdevimab reduced COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. A benefit has not been shown in patients hospitalized due to COVID-19. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated.

    Read the FDA announcement.

    Posted 11/23/2020



  • Pfizer + BioNTech Announce EUA Request to FDA for COVID-19 Vaccine

    On November 20, 2020, Pfizer and BioNTech announced that they have submitted a request to the U.S. Food and Drug Administration (FDA) for an emergency use authorization (EUA) for BNT162b2, the companies’ COVID-19 mRNA vaccine candidate. If approved, some Americans could receive the vaccine as early as mid-December. 


    Through an accelerated clinical trial process, the potential vaccine demonstrated a 95 percent efficacy rate with no serious safety concerns to date. The companies expect to produce up to 50 million doses globally in 2020 and up to 1.3 billion by the end of 2021. 


    The companies have also initiated rolling submissions with regulatory agencies around the world. Upon authorization, the companies state that they will be ready to distribute the vaccine within hours. 


    Read Pfizer's announcement. Find out more about Pfizer and BioNTech’s COVID-19 vaccine candidate from AP NewsNew York Times, and Washington Post


    Posted 11/20/2020



  • FDA Issues EAU for Monoclonal Antibody to Treat COVID-19

    On November 9, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for bamlanivimab, an investigational monoclonal antibody therapy, for the treatment of mild to moderate COVID-19 in adult and pediatric patients who:

    • 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



  • Registration Open: Review of Efficacy and Safety of Monjuvi® (tafasitamab-cxix)

    incyte-logoMonjuvi® (tafasitamab-cxix, Incyte) in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory 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 (ASCT).

    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(s).

    Join a one-hour webcast, Review of Efficacy and Safety of Monjuvi (tafasitamab-cxix): FDA-approved monoclonal antibody in combination with lenalidomide for adult patients with R/R DLBCL who have received at least one prior therapy, to learn more about the usage of Monjuvi®, (tafasitamab-cxix) in treating your patients. 

    Wednesday, December 16
    1:00 - 2:00 PM EST

    Presented by:
    Moshe Levy, MD
    Director of Hematologic Malignancies Research; Hematology Associate
    Texas Oncology, PA; Baylor University College of Medicine

    REGISTER

    Wednesday, December 16
    3:00 - 4:00 PM EST

    Presented by:
    John Pagel, MD
    Chief of Hematologic Malignancies and Director of Stem Cell Transplantation
    Swedish Cancer Institute

    REGISTER



  • FDA Approves Pembrolizumab + Chemotherapy for TNBC

    On November 13, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Keytruda® (pembrolizumab) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test.

    Read the FDA announcement.

    Read the Merck press release.

    Posted 11/16/2020


  • Registration Open: Jakafi (ruxolitinib) Product Theater

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

    incyte-logoJakafi® (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

    On October 15, 2020, the U.S. Food and Drug Administration (FDA) approved an expanded label for Keytruda® (pembrolizumab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL). Keytruda is the first anti-PD-1 therapy approved for adult patients with relapsed or refractory cHL after frontline therapy.

    Read Merck's press release and the FDA announcement.

    Posted 10/15/2020


  • Webcast for Lynparza PAOLA-1 Launch

    Join professionals from across the country for an expert discussion on Lynparza (olaparib, AstraZeneca), and Lynparza + bevacizumab as maintenance monotherapy or combination therapy in advanced ovarian cancer: results from key clinical trials.

    Important Notes

    • Members will be directed to a registration site which will give them the option to choose from all 6 webcasts

    • Members will be required to input their information to register for an event

    • Members can add the event to their calendar from the registration site or the registration confirmation email

    • Members will receive a reminder email 1 day and 30 minutes prior to the webcast

    Details and registration.



  • Ibrutinib for the Treatment of Adult Patients with CLL/SLL

    Ibrutinib (Imbruvica®, Pharmacyclics) is a once-daily oral therapy indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Ibrutinib is also indicated for the treatment of adult patients with CLL/SLL with 17p deletion.


    Read efficacy study and prescribing information

    To help guide and assist patients during treatment, Pharmacyclics the YOU&iTM 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 ReleaseFact 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

    On September 1, 2020 the U.S. Food and Drug Administration (FDA) approved Onureg® (azacitidine) for the continued treatment of patients with acute myeloid leukemia (AML) who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy.

    Read the Bristol Myers Squibb announcement.

    Read the FDA announcement.

    Posted 9/2/2020



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