FDA Commissioner Scott Gottlieb has taken to Twitter to say that due to the partial shutdown, the FDA cannot accept new 2019 user fees.
FDA Commissioner Scott Gottlieb has taken to Twitter again to state the FDA “continues to be concerned about branded companies creating confusion about the safety and effectiveness of biosimilars and we'll take action if we determine a company is deliberately misleading the public about the safety of these important products.”
AstraZeneca and Merck said FDA has approved Lynparza for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
FDA has expanded the indication for Sprycel (dasatinib) tablets to include the treatment of pediatric patients one year of age and older with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in combination with chemotherapy.
Merck said FDA has approved Keytruda for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma, based on the results of the Cancer Immunotherapy Trials Network's CITN-09/KEYNOTE-017 trial.
Merck said FDA has extended the action date for the supplemental Biologics License Application for Keytruda as monotherapy for the first-line treatment of locally advanced or metastatic NSCLC in patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) without EGFR or ALK genomic tumor aberrations.
Merck said Keytruda (pembrolizumab), an anti-PD-1 therapy, has simultaneously received five new approvals from the Japan Pharmaceuticals and Medical Devices Agency, including three expanded uses in advanced non-small lung cancer, one in melanoma, as well as a new indication in advanced microsatellite instability-high tumors. The following new approvals were all granted priority review by the PMDA:
The Ministry of Health, Labour and Welfare of Japan has approved FoundationOne CDx as a comprehensive genomic profiling test for all solid tumors and a broad companion diagnostic for individuals living with advanced cancer.
FDA approved calaspargase pegol-mknl (ASPARLAS, Servier Pharmaceuticals LLC), an asparagine specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. This new product provides for a longer interval between doses, compared to other available pegaspargase products.
Gritstone Oncology Inc. said FDA has granted Fast Track designation to GRANITE-001 for the treatment of colorectal cancer. GRANITE-001 is a personalized immunotherapy containing patient-specific neoantigens identified by Gritstone's proprietary EDGETM artificial intelligence platform as the most relevant neoantigens to drive a tumor-specific T-cell attack.
