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.
Patients treated with chemotherapy for most solid tumors during 2000–2014 experienced an increased risk of therapy-related myelodysplastic syndrome/acute myeloid leukemia, a study by NCI researchers shows.
New research from Europe, published in the December 2018 issue of JNCCN—Journal of the National Comprehensive Cancer Network, finds that quality-of-life for people with cancer is reduced by an accumulation of low-level toxicities just as much as it is from high-level adverse events.
Astellas Pharma Inc. and Pfizer Inc. announced that the phase III ARCHES trial evaluating XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC) met its primary endpoint, significantly improving radiographic progression-free survival (rPFS) versus ADT alone. The preliminary safety analysis of the ARCHES trial appears consistent with the safety profile of XTANDI in previous clinical trials in castration-resistant prostate cancer (CRPC). Detailed results will be submitted for presentation at an upcoming medical congress.
G1 Therapeutics Inc. announced positive topline data showing multi-lineage myelopreservation benefits in its randomized, double-blind, placebo-controlled phase II trial evaluating trilaciclib in combination with topotecan as a treatment for 2nd-/3rd-line small cell lung cancer (2/3L SCLC).
