FDA Approves Pembrolizumab for TMB-High Solid TumorsJune 17th 2020
The FDA has approved pembrolizumab (Keytruda) to treat adult and pediatric patients with unresectable or metastatic solid tumors that are tissue tumor mutational burden–high (≥10 mutations/megabase) and have progressed following prior therapy and who have no satisfactory alternative treatment options.
FDA Expands Gardasil 9 Approval for HPV-Related CancersJune 15th 2020
On Friday, the FDA expanded the approval for Gardasil 9 for the prevention of oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) types 16,18,31, 33, 45, 52, and 58, according to Merck, the manufacturer of the vaccine.
Margetuximab Granted Orphan Drug Status for Gastric CancerJune 7th 2020
The FDA has granted margetuximab an Orphan Drug designation for the treatment of patients with gastric and gastroesophageal junction (GEJ) cancer, according to MacroGenics, Inc., the manufacturer of the Fc-engineered monoclonal antibody.
FDA Accepts BLA for Ropeginterferon Alfa-2b for PV TreatmentJune 5th 2020
The FDA has accepted a Biologics License Application (BLA) for ropeginterferon alfa-2b (P1101) for use as a treatment for patients with polycythemia vera (PV) in the absence of symptomatic splenomegaly, according to PharmaEssentia Corporation, the manufacturer of the novel pegylated interferon.
FDA Approves Ramucirumab + Erlotinib for Firstline EGFR+ NSCLCMay 30th 2020
The FDA has approved the combination of ramucirumab (Cyramza) and erlotinib (Tarceva) as a frontline treatment for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors harbor EGFR exon 19 deletions (Ex19del) or exon 21 (L858R) substitution mutations.
sNDA Submitted to the FDA for Earlier Selinexor Treatment in MyelomaMay 21st 2020
Karyopharm Therapeutics Inc. has submitted a supplemental New Drug Application (sNDA) to the FDA for the use of selinexor (Xpovio) as a treatment for patients with multiple myeloma following at least 1 line of prior therapy.
FDA Extends Review Period for Liso-Cel for Lymphoma TreatmentMay 6th 2020
The FDA has added 3 months to the review period for a biologics license application (BLA) for lisocabtagene maraleucel (liso-cel) for the treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) after at least 2 prior therapies. The extension will allow the agency to review additional data provided by Bristol Myers Squibb, the manufacturer of the anti-CD19 CAR T-cell therapy.
FDA Grants Priority Review to CC-486 for the Treatment of Acute Myeloid LeukemiaMay 1st 2020
The FDA granted priority review to a new drug application for CC-486 for the maintenance treatment of adult patients with acute myeloid leukemia based on efficacy and safety results from the pivotal phase III QUAZAR AML-001 study.
FDA Approves Niraparib for Maintenance Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal CancerApril 29th 2020
The FDA approved niraparib for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to frontline platinum-based chemotherapy.