Industry News Archive

  • FDA Approves Additional Indication for Pembrolizumab

    Pembrolizumab (Keytruda®, Merck) has received FDA approval, in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express programmed death ligand 1 (PD-L1) [combined positive score (CPS ≥10)] as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

    Select patients for treatment with KEYTRUDA in combination with chemotherapy based on the presence of positive PD-L1 expression in:
    - locally recurrent unresectable or metastatic TNBC

    Read prescribing information and Medication Guide.

    Posted on 12/07/2020


     


  • FDA Approves Pralsetinib for RET-Altered Thyroid Cancers

    On December 1, 2020, the U.S. Food and Drug Administration (FDA) approved pralsetinib for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

    Read the FDA announcement.

    Read Genentech's announcement.

    Posted 12/2/2020



  • 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



  • 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 Venetoclax in Combination for Untreated AML

    On October 16, 2020, the U.S. Food and Drug Administration (FDA) granted regular approval to Venclexta® (venetoclax) in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities precluding intensive induction chemotherapy.

    Venetoclax was initially granted accelerated approval for this indication in November 2018.

    Read Roche's announcement and the FDA announcement.

    Posted 10/19/2020




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