Industry News

  • 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 News, New 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



  • 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


  • 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




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