Immunomedics Inc.’s cancer drug Trodelvy, which received accelerated U.S. regulatory approval in April 2020, extended survival time in previously treated patients with an advanced form of breast cancer in a clinical trial.
The U.S. Food and Drug Administration granted accelerated approval for NS Pharma’s Viltepso (viltolarsen) injection for patients with Duchenne muscular dystrophy who are amenable to exon 53 skipping therapy.
The U.S. Food and Drug Administration approved ViiV Healthcare’s Dovato (dolutegravir/lamivudine) as a complete regimen for the treatment of HIV-1 infection to replace the current antiretroviral regimen in adults who are virologically suppressed on a stable ARV regimen with no history of treatment failure and no known resistance to the individual components of Dovato.
The U.S. Food and Drug Administration granted accelerated approval to Gilead Company Kite’s Tecartus (brexucabtagene autoleucel, formerly KTE-X19) as the first approved chimeric antigen receptor T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
The U.S. Food and Drug Administration approved Jazz Pharmaceuticals and company partner PharmaMar’s Zepzelca (lurbinectedin) for adults with metastatic small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy.
The U.S. Food and Drug Administration approved Clovis Oncology Inc.’s Rubraca (rucaparib) tablets for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
Eli Lilly is moving quickly to get the newly approved precision oncology treatment Retevmo for certain lung and thyroid cancers into the hands of patients.
Neurelis Inc. announced the commercial availability of Valtoco (diazepam nasal spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in adult and pediatric patients 6 years of age and older.
On Valentine’s Day, BioSpace would be remiss not to mention, er, matters of the heart. There are reportedly 59 life sciences companies or organizations worldwide that focus on the cardiovascular system, ranging from the Aab Cardiovascular Research Institute based in West Henrietta, New York to XyloCor Therapeutics, with headquarters in Philadelphia. That number is probably low.
Two months after Pfizer and Astellas’ Xtandi won regulatory approval for a new indication in prostate cancer, the companies released positive new data in another type of prostate cancer.