The agency made its decision based on the SOLAR-1 study showing a five-month progression-free survival benefit for Piqray plus fulvestrant over just fulvestrant.
In ASCO studies, one PI3K inhibitor showed efficacy in PIK3CA-mutated breast cancer patients progressing on CDK4/6 inhibitors, while the other yielded less encouraging signals.
The oral MET inhibitor, marketed as Tabrecta, is for patients whose tumors have a mutation that leads to MET exon 14 skipping as detected by a Foundation Medicine test.
With the help of a companion diagnostic, the firm plans to file a new drug application with the FDA for the previously abandoned TKI in the second half of 2020.
A study evaluated data from a Phase I/II trial of Piqray combined with an aromatase inhibitor to find mechanisms of resistance hindering clinical benefit from the therapy.