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Oncology Newsfeed

  • FDA Approves Expanded Indication for Pembrolizumab for cSCC

    On July 6, 2021, the U.S. Food and Drug Administration (FDA) approved an expanded label for pembrolizumab as a monotherapy treatment for patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

    Read Merck's announcement.

    Posted 7/6/2021


  • FDA Approves FoundationOne® CDx as Companion Diagnostic for Brigatinib

    On July 1, 2021, the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx as a companion diagnostic for brigatinib, which is currently FDA-approved for the treatment of adult patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer as detected by an FDA-approved test.

    Read the Foundation Medicine announcement.

    Posted 7/1/2021



  • FDA Approves Component of Chemotherapy Regimen for ALL and LBL

    On June 30, 2021, the U.S. Food and Drug Administration (FDA) approved asparaginase erwinia chrysanthemi (recombinant)-rywn as a component of a multi-agent chemotherapy regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment.

    Read the FDA announcement.

    Read the Jazz Pharmaceuticals announcement.

    Posted 7/1/2021


  • FDA Encourages Inclusion of Patients with Incurable Cancers in Clinical Trials

    On June 24, 2021, the U.S. Food and Drug Administration (FDA) issued drafted guidance that encourages the inclusion the patients with incurable cancers in clinical trials, regardless of their treatment history. When finalized, the FDA's guidance will "provide recommendations to sponsors designing clinical trials of drug and biological products to expand eligibility to patients with incurable cancers."

    It will also provide guidance on how to address patients who have not received prior therapies, such as using separate cohorts.

    Read the full FDA draft guidance for sponsors.

    Posted 6/25/2021


  • FDA Approves Avapritinib for Advanced Systemic Mastocytosis

    On June 16, 2021, the U.S. Food and Drug Administration (FDA) approved avapritinib for the treatment of adult patients with advanced systemic mastocytosis (SM), including aggressive SM, SM with an associated hematological neoplasm, and mast cell leukemia.

    Read the FDA announcement.

    Read Blueprint Medicines' announcement.

    Posted 06/17/2021


  • FDA Grants Accelerated Approval to Infigratinib for Cholangiocarcinoma

    On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to infigratinib for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

    Read the FDA announcement.

    Read the QED Therapeutics announcement.

    Posted 6/1/2021



  • FDA Approves Guardant360® CDx Test for NSCLC with KRAS G12C Mutation

    On May 28, 2021, the U.S. Food and Drug Administration approved the Guardant360® CDx test for tumor mutation profiling or comprehensive genomic profiling to identify patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who harbor the KRAS G12C mutation and may benefit from Lumakras™ (sotorasib), an FDA-approved KRASG12C inhibitor developed and manufactured by Amgen.

    Read the Guardant Health announcement.

    Posted 6/1/2021



  • FDA Grants Accelerated Approval to Sotorasib for NSCLC

    On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sotorasib for adult patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy.

    Read the FDA announcement.

    Read the Amgen announcement.

    Posted 6/1/2021



  • FDA Approves Companion Diagnostic for Amivantamab-vmjw

    On May 21, 2021, the U.S. Food and Drug Administration approved the Guardant360® CDx liquid biopsy test as the first and only companion diagnostic for amivantamab-vmjw.

    The Guardant360 CDx test will be used for tumor mutation profiling or comprehensive genomic profiling to identify patients with locally advanced or metastatic non-small cell lung cancer who harbor the EGFR exon 20 insertion mutation and may benefit from targeted treatment with amivantamab-vmjw after progressing on or after platinum-based chemotherapy.


    Read Guardant Health's announcement.

    Posted 5/24/2021



  • FDA Approves Amivantamab-vmjw for Subset of NSCLC

    On May 21, 2021, the U.S. Food and Drug Administration (FDA) approved mivantamab-vmjw as the first treatment for adult patients with non-small cell lung cancer (NSCLC) whose tumors have specific types of genetic mutations: epidermal growth factor receptor exon 20 insertion mutations.

    Read the FDA announcement.

    Posted 5/21/2021