Oncology, Regulatory

Delay brings success for Roche as it finally wins FDA nod for Tecentriq regimen in frontline lung cancer

Roche’s eagerly-anticipated approval for a combination of its immunotherapy Tecentriq and anti-VEGF Avastin in addition to chemotherapy in frontline lung cancer is finally here — the FDA sanctioned the approval on Thursday after initially delaying its decision.

The Swiss drugmaker will now do its best to carve itself a bigger piece of the lucrative oncology market, which is already largely divided between leaders Merck $MRK and Bristol-Myers Squibb $BMY, which have long established their respective checkpoint inhibitors.

The agency deferred the PDUFA date by three months in September after soliciting additional information from Roche, which had already detailed impressive data on the triple regimen: a doubling in 12-month progression-free survival rates, and significant gains in overall survival, compared to Avastin and chemotherapy for a broad group of patients with non-squamous non-small cell lung cancer (NSCLC) in the keenly-watched IMpower150 study.

Tecentriq has already secured approved for use in patients with metastatic NSCLC whose disease has progressed during or following platinum-containing chemotherapy, or an FDA-approved targeted therapy if their tumor has EGFR or ALK genetic alterations. The drug, which is also used in patients with urothelial carcinoma, generated sales of 320 million Swiss Francs CHF (about $322 million) in the first half of 2018.

More than 234,000 Americans will be diagnosed with lung cancer in 2018, and NSCLC accounts for 85% of all lung cancers, estimates the American Cancer Society.


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