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The agent has been approved for both treatment-naïve and previously treated patients whose tumors have a mutation that leads to MET exon 14 skipping.
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.
At the AACR meeting, investigators presented complete data from a Phase II trial that is supporting Novartis' drug approval application with the FDA.
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.
In the upcoming clinical trial, the companies will evaluate the effects of IDEAYA's PKC inhibitor IDE196 and Pfizer's MEK inhibitor binimetinib.
Capmatinib is being studied as a therapy for untreated and previously treated MET exon 14 skipping mutated non-small cell lung cancer patients.
In patients with Luminal B tumors the CDK4/6 inhibitor ribociclib along with hormonal therapy produced response rates similar to multi-agent chemotherapy.