Roche's (RHHBY) Cancer Drug Gets FDA Nod For Label Expansion

Roche Holding (SIX:ROG) AG’s (OTC:RHHBY) unit, Genentech, announced that its drug Tecentriq (atezolizumab) has received FDA approval on an accelerated basis for initial treatment of people with advanced urothelial carcinoma (mUC) - a form of bladder cancer - who are unable to receive initial treatment with cisplatin chemotherapy.

Tecentriq is already approved for the treatment locally advanced mUC in patients whose disease has progressed after receiving other medicines, either before or after surgery, or after their disease has spread.

Roche’s share price shows that the company has outperformed the Zacks classified industry year to date. The stock is up 12.5% compared with the Large Cap Pharmaceuticals industry’s gain of 5.4%.

Also, in October last year, Tecentriq became the first and the only anti-PDL1 cancer immunotherapy to be approved by the FDA for the treatment of metastatic non-small cell lung cancer (NSCLC).

The label expansion of the drug is expected to boost sales for the company. As per the press release, bladder cancer is the most common type of urothelial carcinoma and about half the people with the advanced form of the disease are unable to receive cisplatin chemotherapy as an initial treatment, thereby leading to a high unmet medical need. Urothelial carcinoma also includes cancers of the urethra, ureters and renal pelvis.

The accelerated approval of Tecentriq was granted based on tumor response rate and duration of response. Also, it was based on Phase II IMvigor210 study. But the final approval will be give only of the drug showsclinical benefit in confirmatory studies.

However, stiff competition in the immunotherapy space with players like Bristol-Myers Squibb (NYSE:BMY) boasts a robust portfolio with drugs like Opdivo and Yervoy. Merck’s (NYSE:MRK) Keytruda also poses strong competition with approvals for a varied range of cancers.

Last week, Roche announced that the global randomized phase III study, ALEX, on lung cancer drug Alecensa met its primary endpoint as an initial (first-line) treatment. According to the evaluation, Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared with Pfizer’s (NYSE:PFE) Xalkori in patients suffering from anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

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Zacks Rank

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

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