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The approval will make Merck and AstraZeneca's Lynparza available to patients in the EU who have not progressed after 16 weeks on platinum-based chemotherapy.
Healthcare professionals can inject the regimen, containing Perjeta, Herceptin, and hyaluronidase, in patients' homes after intravenous chemotherapy.
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.
Some oncologists said 10 mutations/Mb is an acceptable TMB cutoff in patients who are out of options, while others worry it will drive immunotherapy use in those unlikely to have a lasting benefit.
The accelerated approval is based on data showing that refractory cancer patients with TMB of at least 10 mutations/Mb saw tumor shrinkage and had durable responses on the immunotherapy.
The agency approved the drug based on a study that showed that Mylotarg combined with chemo extended event-free survival compared to chemo alone.
The decision is based on pooled single-arm trial data demonstrating the agent's ability to prolong progression-free survival and shrink patients' tumors.
The agency granted accelerated approval based on the vaccine's ability to prevent HPV-related anogenital disease, but a 6,000-patient study will assess its ability to prevent oral cancer.
The agency based its decision on a trial showing that patients receiving the combo had a median PFS of 19.4 months versus 12.4 months for those on Tarceva.
The approval follows another recent approval for the two Bristol Myers Squibb agents without chemotherapy indicated for patients with PD-L1 scores of 1 percent or above.