Roche Holdings AG (RHHBY - Free Report) announced that the review period for the supplemental Biologics License Application (sBLA) for Tecentriq in combination with Avastin, carboplatin and paclitaxel for the initial treatment of patients suffering from metastatic non-squamous non-small cell lung cancer (NSCLC) has been extended by three months.
The FDA stated that the submission of this information constituted a major amendment to the sBLA, resulting in the extension of the PDUFA goal date. The extension of three months will allow the FDA take time to review additional information requested in support of the sBLA.
A decision from the FDA on approval is expected by Dec 5, 2018.
We note that Tecentriq in combination with Avastin was granted priority review by the FDA for the initial treatment of people with metastatic non-squamous NSCLC based on results from the phase III study, IMpower150, in May 2018. We remind investors that Tecentriq is already approved in the EU, and the United States for previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).
Sales of Tecentriq came in at CHF 320 million, up 37% in the first half of 2018.
Meanwhile, Roche is working to expand the immuno-oncology drug’s label. The company has eight phase III lung cancer studies underway, evaluating Tecentriq alone or in combination with other drugs.
NSCLC market holds great promise, particularly for the first-line treatment, but competition is stiff as well with the likes of Merck’s (MRK - Free Report) Keytruda and Bristol-Myers Squibb Company’s (BMY - Free Report) Opdivo.
Approval of new drugs and label expansion of existing key drugs bode well for Roche, given its current challenges.
Year to date, shares of Roche have declined 3.6% against the industry’s growth of 4.2%. Roche’s legacy drugs like Herceptin and MabThera are facing competition from biosimilars. Novartis (NVS - Free Report) has already launched its biosimilar version of Rituxan/ MabThera in Europe.
Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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