The FDA approved trastuzumab deruxtecan (Enhertu, AstraZeneca/Daiichi Sankyo) on 12/19/19, for the treatment of unresectable or metastatic HER2-positive breast cancer that has received two or more prior anti-HER2-based regimens in the metastatic setting.
The FDA approved Merck’s Ebola virus vaccine (Ervebo) on 12/20/19, for the prevention of Ebola virus disease caused by the Zaire ebola virus in people at least 18 years old.
The FDA approved enfortumab vedotin (Padcev, Astellas/Seattle Genetics) on 12/18/19 for the treatment of locally advanced or metastatic urothelial cancer that has progressed on chemotherapy and immunotherapy.
The FDA rejected ViiV Healthcare/Janssen’s NDA for the combination of cabotegravir and rilpivirine for HIV treatment, due to manufacturing issues.
The FDA’s review of tazemetostat found a lack of efficacy compared to standard therapies and the potential for secondary malignancies that short trial durations may not have fully described. But the FDA’s Oncologic Drugs Advisory Committee voted 11-0 with two abstentions to recommend approval of tazemetostat for the treatment of metastatic or inoperable locally advanced epithelioid sarcoma, due to the low response rate with currently approved treatments.
Deciphera filed an NDA for ripretinib for the treatment of gastrointestinal stromal tumors.
The FDA designated Orphazyme’s arimoclomol a Fast Track drug for the treatment of sporadic Inclusion Body Myositis.
PharmaMar submitted an NDA for lurbinectedin for the treatment of small cell lung cancer.
The FDA designated Cascadian Therapeutics’ tucatinib a Breakthrough Therapy when given in combination with trastuzumab and capecitabine, for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer.
BMS filed a BLA for lisocabtagene maraleucel for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least two prior therapies.
MacroGenics filed a BLA for margetuximab for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy.
Gilead submitted an NDA for filgotinib for the treatment of moderate-to-severe rheumatoid arthritis.
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