FDA has allowed Athenex Inc.'s Investigational New Drug application for the clinical investigation of PT01 (Pegtomarginase) for the treatment of patients with advanced malignancies.
Intensity Therapeutics Inc. has entered into an agreement with Merck to evaluate the combination of Intensity's lead product candidate INT230-6 and Keytruda (pembrolizumab), Merck's anti-PD-1 therapy, in patients with advanced solid malignancies including pancreatic, bile duct, squamous cell, and non-MSI high colon cancers.
OncoSec Medical Inc. announced it has entered into a collaboration with Dana-Farber Cancer Institute, and The Marasco Laboratory, led by Wayne Marasco, to develop CAR-T cell therapies for triple-negative breast cancer and other solid tumors.
Integrated Oncology Network announced it has acquired e+CancerCare. Founded in 2002, e+CancerCare provides a complete integrated continuum of care, including diagnostic testing, radiation oncology, medical oncology and ancillary services.
FDA has granted accelerated approval to pembrolizumab (Keytruda) for patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
FDA approved Amgen and Allergan Kanjinti's (trastuzumab-anns) for all approved indications of the reference product, Herceptin (trastuzumab) for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
The European Commission has approved Lynparza as monotherapy for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
Japan's Pharmaceuticals and Medical Devices Agency has approved Lynparza as a maintenance treatment after first-line chemotherapy in patients with BRCA-mutated ovarian cancer.
Myriad Genetic Laboratories Inc. said the Japanese Ministry of Health, Labour, and Welfare has granted a second manufacturing and marketing approval for Myriad's BRACAnalysis Diagnostic System as a companion diagnostic with the PARP inhibitor, Lynparza (olaparib).
Gilead Sciences Inc. and Nurix Therapeutics Inc. formed a collaboration to discover, develop, and commercialize a pipeline of innovative targeted protein degradation drugs for patients with cancer and other challenging diseases.
