Roche’s immunotherapy combo receives FDA priority review

By Brittany Farb Gruber

- Last updated on GMT

(Image: Getty/Tashatuvango)
(Image: Getty/Tashatuvango)
Roche’s immunotherapy combination has received priority review after Phase III trial results showed potential to provide significant survival benefit in the initial treatment of NSCLC.

The US Food and Drug Administration (FDA) has granted Roche priority review for Tecentriq (atezolizumab), in combination with Avastin (bevacizumab​), paclitaxel and carboplatin (chemotherapy), as a first-line treatment for metastatic non-squamous non-small cell lung cancer (NSCLC).

Roche currently has eight Phase III lung-cancer studies underway to evaluate Tecentriq, a monoclonal antibody (mAb) designed to bind with a protein called PD-L1.

The FDA’s priority review requires the regulator to take action on the application within six months, instead of the standard ten. These designations are awarded to medications that provide significant improvements in the treatment, prevention or diagnosis of a disease.

The FDA is expected to make a decision on approval by Sept. 5.

Pre-existing approval

Tecentriq has already received FDA approval to treat patients diagnosed with metastatic no-squamous non-small cell lung cancer (NSCLC) who experience disease progressions following chemotherapy. In addition to US approval, Tecentriq is also approved in the EU and more than 60 additional countries worldwide.

Genentech, the manufacturer of Tecentriq and a subsidiary of Roche, reported in March that the Tecentriq regimen also significantly improved overall survival compared with Avastin and chemotherapy alone.

Checkpoints

Tecentriq joins Merck & Co’s Keytruda​ (pembrolizumab) and Bristol-Myers Squibb’s Opdivo​ (nivolumab) as the “checkpoint inhibitor” drugs on the market.

While Keytruda is also approved for initial lung cancer treatment in some patients, ongoing studies in lung cancer and others could make Tecentriq competitive in the market of first-line treatment of NSCLC.

Last year, sales in Roche’s pharmaceuticals division increased 5% to 41.2bn Swiss francs. Tecentriq, Ocrevus, and Alecensa, contributed 1.4bn Swiss franc in new sales – representing 65% of the division’s growth, according to the company​.

In the first quarter of 2018​ sales in the pharmaceuticals division were up 7%, driven mainly by Ocrevus and Perjeta.

Roche could not provide any additional comments. 

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