FDA granted accelerated approval to the drug enfortumab vedotin to treat adult patients with advanced urothelial or bladder cancer.
FDA granted clearance to IceCure Medical Ltd.'s cryoablation technology that destroys benign and cancerous tumors by freezing them.
Health Canada has approved Calquence (acalabrutinib), an oral Bruton's tyrosine kinase inhibitor, as monotherapy or in combination with obinutuzumab in the first-line setting, and as monotherapy for relapsed/refractory (r/r) disease for the treatment of adult patients with chronic lymphocytic leukemia.
FDA approved Lynparza (olaparib) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.
FDA approved Xtandi (enzalutamide) for patients with metastatic castration-sensitive prostate cancer
FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
FDA granted accelerated approval to Padcev (enfortumab vedotin-ejfv) Dec. 18 for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 or programmed death-ligand 1 inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
FDA granted avatrombopag Orphan Drug designation for the potential treatment of chemotherapy-Induced thrombocytopenia.
Karyopharm Therapeutics Inc. has submitted a New Drug Application to FDA, seeking accelerated approval for Xpovio (selinexor), the company's first-in-class, oral selective inhibitor of nuclear export (SINE) compound, as a new treatment for patients with relapsed or refractory diffuse large B-Cell lymphoma after at least two prior multi-agent therapies and who are ineligible for stem cell transplantation, including CAR-T cell therapy.
Amgen and Allergan plc. submitted a Biologics License Application to FDA for ABP 798, a biosimilar candidate to Rituxan (rituximab).
