FDA approved Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) Sept. 19 for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted two positive opinions for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy.
AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application for Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab has been accepted and granted Priority Review in the U.S. FDA for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
FDA approved gemcitabine intravesical system (Inlexzo) for adults with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.
FDA approved Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) injections, biosimilars of Prolia and Xgeva respectively, for the treatment of osteoporosis. In addition, FDA granted provisional interchangeability designation for both Bosaya and Aukelso.
FDA approved selumetinib (Koselugo) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN.
FDA and Telix have reached an agreement regarding resubmission of its New Drug Application for TLX101-CDx (Floretyrosine F18 or 18F-FET, Pixclara), an investigational agent for the imaging of glioma, a rare and life-threatening brain cancer.
The European Commission granted conditional marketing authorization to Zemcelpro for the treatment of adults with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available.
Exact Sciences Corp. announced the launch of the Cancerguard test, a multi-cancer early detection blood test that is now available as a laboratory-developed test in the United States.
N-Power Medicine, an oncology drug development company, and VieCure, a company focused on AI-powered oncology intelligence, have announced a partnership to bring N-Power Medicine’s proprietary Kaleido Registry to the VieCure network.
