FDA approves six NMEs in November

A pair of firsts headlined FDA’s six new molecular entity approvals last month: the first-ever approval of an AKT inhibitor, and the first therapy of any mechanism for patients with desmoid tumors requiring systemic therapy.

On Nov. 16, FDA approved AKT inhibitor Truqap capivasertib from AstraZeneca plc (LSE:AZN; NASDAQ:AZN), in combination with fulvestrant, to treat hormone receptor-positive, HER2-negative breast cancer with PIK3CA, AKT or PTEN biomarker alterations. The approval was based on the Phase III CAPItello-291 trial, in which the treatment arm had 7.3 months of progression-free survival (PFS) vs. 3.1 months in the placebo arm. Truqap is an ATP competitive inhibitor of all three isoforms of AKT that play a part in promoting tumor cell proliferation and inhibiting apoptosis. BioCentury’s BCIQ database lists 23 other AKT inhibitors in the clinic, of which three are in Phase III testing. ...