May 1 (Reuters) – The U.S. Food and Drug Administration on Friday approved Pfizer and Arvinas’ breast cancer drug for patients with an advanced form of the disease whose tumors carry a specific genetic mutation.
Branded as Veppanu, the pill is authorized for adults with estrogen receptor-positive, HER2-negative breast cancer, which has already spread or cannot be removed by surgery.
Patients must carry an ESR1 mutation and show disease progression after at least one prior hormone therapy, the agency said.
The approval is a “transformative moment for Arvinas as we achieve our first approved medicine and the first-ever approved PROTAC therapy based on the technology we’ve pioneered since 2013,” said Arvinas CEO Randy Teel.
The FDA’s decision was based on a late-stage trial of 624 participants that showed Veppanu helped patients survive for longer periods without their breast cancer worsening compared with the older hormone therapy fulvestrant.
Patients taking the pill also saw their tumors shrink more often than those given the injection, the FDA said.
The drug’s label, however, cautions that it can affect heart rhythm and may harm an unborn baby.
The FDA also approved a companion blood test, Guardant360 CDx, to identify which patients carry the ESR1 mutation and are eligible for the drug.
The recommended dose is a 200mg pill taken once a day with food, until the disease worsens or side-effects become too severe, the health regulator said.
Arvinas and Pfizer said they plan to choose an outside partner to help market Veppanu and expect to announce their selection soon.
Shares of Arvinas rose 3.7%, while Pfizer was down about 1% in afternoon trading.
(Reporting by Sriparna Roy, Kamal Choudhury and Padmanabhan Ananthan in Bengaluru; Editing by Shreya Biswas and Shilpi Majumdar)
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