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The firm is exploring whether the regimen may work for subgroups of patients with high TMB based on promising signals from the current failed analysis.
An initial program aims at the development of a serum neurofilament light chain immunoassay to support Novartis' MS and other neuroscience programs.
The first prospective study of BRAF-mutated cholangiocarcinoma showed a 51 percent response rate among patients treated with Novartis' Tafinlar and Mekinist.
The drugmaker said it is working with centers of excellence in Canada to set up companion diagnostic testing to identify patients with PIK3CA mutations.
Following positive Phase II results, the company plans to seek US and EU approval for the CAR T-cell therapy in relapsed or refractory follicular lymphoma in 2021.
The commission took the earlier CHMP recommendation to approve the treatment based on the positive results from the Phase III SOLAR-1 trial.
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.