The U.S. Food and Drug Administration approved G1 Therapeutics’ Cosela (trilaciclib) for injection to decrease the damage to the immune system and bone marrow from chemotherapy.
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted against recommending Merck’s checkpoint inhibitor Keytruda (pembrolizumab) as neoadjuvant treatment for high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy after surgery.
AstraZeneca reported that the company’s Phase III KESTREL trial of Imfinzi (durvalumab) failed to meet the primary endpoint of improving overall survival compared to the EXTREME treatment regimen, which was chemotherapy plus cetuximab, a standard of care.
The chemotherapy pralatrexate and the antibiotic azithromycin were successful at preventing replication of the SARS-CoV-2 virus, according to research with Shenzhen Institutes of Advanced Technology in China.
Shares of Aprea Therapeutics plunged after the Boston-based company announced a late-stage cancer combination treatment failed to meet the primary endpoint of complete remission rate.
The U.S. Food and Drug Administration approved MacroGenics Inc.’s drug Margenza in combination with chemotherapy for the treatment of an advanced type of breast cancer in patients who failed two or more prior therapies.
The Janssen Pharmaceutical Companies of Johnson & Johnson submitted a Biologics License Application to the U.S. Food and Drug Administration seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 as determined by an FDA-approved test.
The U.S. Food and Drug Administration granted Roche’s Venclexta (venetoclax) full approval in combination with azacytidine, or decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia in adults 75 years or older.
The U.S. Food and Drug Administration granted full approval of Genentech’s Venclexta (venetoclax) in combination with azacitidine, or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.