The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for JNJ-61186372 (JNJ-6372) 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.
Debiopharm announced that the U.S. Food and Drug Administration granted a Breakthrough Therapy Designation for Debio 1143, the most clinically advanced IAP antagonist, for the treatment of patients with confirmed diagnosis of previously untreated, unresectable locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) in combination with current standard of care (CRT).
The bladder cancer drug Padcev, which was approved by the U.S. Food and Drug Administration in December, secured Breakthrough Therapy designation for the treatment of patients with another type of bladder cancer.
Although January 2020 was a fairly slow month for PDUFA dates for the U.S. Food and Drug Administration, February has a stronger schedule.
The U.S. Food and Drug Administration granted Breakthrough Therapy designation to Austin, Texas-based Savara Inc.’s Molgradex for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP).
Usona Institute received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for psilocybin in the treatment of major depressive disorder (MDD).
Novartis secured U.S. FDA Breakthrough Therapy Designation for the investigational medicine capmatinib, which the company aims to file for approval during 2019 against a mutated form of lung cancer.
AstraZeneca’s BTK inhibitor Calquence won Breakthrough Therapy Designation from the U.S. FDA as a monotherapy treatment for patients with chronic lymphocytic leukemia (CLL).
The U.S. Food and Drug Administration approved Pfizer Inc.’s oral drug tafamidis to treat a rare and fatal heart disease called transthyretin amyloid cardiomyopathy.
Genfit’s elafibranor was granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of Primary Biliary Cholangitis (PBC) in adults with inadequate response to ursodeoxycholic acid.