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.Â
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 has begun to crack down on direct-to-consumer prescription drug advertising.Â
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.Â
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.Â
Vinay Prasad has regained his role as FDA’s chief medical and scientific officer, according to an update on the agency’s website.
FDA introduced the Rare Disease Evidence Principles to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect.Â
FDA has 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. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.
