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Industry News Archive

  • New FDA-Approved Indication for Crizotinib Capsules

    The U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for crizotinib (Xalkori®, Pfizer) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic leukemia kinase-positive. 

    Read the Full Prescribing Information.

    Read the Press Release.

    Posted 1/26/2021



  • FDA Approves Nivolumab + Cabozantinib for Advanced RCC

    On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma (RCC).

    Read Bristol Myers Squibb's announcement.

    Read the FDA announcement.

    Posted 1/22/2021



  • FDA Approves Crizotinib for Children and YA Patients with R/R ALCL

    On January 14, 2021, the U.S. Food and Drug Administration (FDA) approved crizotinib for pediatric patients 1 year of age and older and young adults (YA) with relapsed or refractory (R/R), systemic anaplastic large cell lymphoma (ALCL)  that is ALK-positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive  ALCL.

    Read the FDA announcement.

    Read Pfizer's announcement.

    Posted 1/15/2021



  • FDA Approves Osimertinib for the Adjuvant Treatment of EGFRm NSCLC

    On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved osimertinib for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumor resection with curative intent.

    Read the FDA announcement.

    Read AstraZeneca's announcement.

    Posted 12/21/2020


  • Durvalumab Dosing Update

    Durvalumab (Imfinzi®, AstraZeneca) has been approved in the U.S. for an additional dosing option for patients with a body weight of 30 kg and more: 1500 mg administered intravenously every four weeks in the approved indication of unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy. Patients with body weight <30 kg must receive weight-based dosing, equivalent to IMFINZI 10 mg/kg every 2 weeks.

    Read the press release.

    Posted on 12/15/2020. 



  • 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



  • 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




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