Time New York: Tue 23 Jul 02:23 am  |  Save 15% on H&R Block Online


Roche’s Tecentriq sBLA Review For NSCLC Gets Extended by FDA


Roche Holdings AG RHHBY 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 Keytruda and Bristol-Myers Squibb Company’s BMY 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 has already launched its biosimilar version of Rituxan/ MabThera in Europe.

Zacks Rank

Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

More Stock News: This Is Bigger than the iPhone!

It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.

Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.

Click here for the 6 trades >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

To read this article on Zacks.com click here.

Zacks Investment Research
<-- You can share this post with your network,
or give us your opinion and leave a comment.
Be sure to check our RSS feeds for updates.