We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Roche's (RHHBY) Cancer Drug Gets FDA Nod for Label Expansion
Read MoreHide Full Article
Roche Holding AG’s (RHHBY - Free Report) 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 (BMY - Free Report) boasts a robust portfolio with drugs like Opdivo and Yervoy. Merck’s (MRK - Free Report) 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 (PFE - Free Report) Xalkori in patients suffering from anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
5 Trades Could Profit "Big-League" from Trump Policies
If the stocks above spark your interest, wait until you look into companies primed to make substantial gains from Washington's changing course. Today Zacks reveals 5 tickers that could benefit from new trends like streamlined drug approvals, tariffs, lower taxes, higher interest rates, and spending surges in defense and infrastructure. See these buy recommendations now >>
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Roche's (RHHBY) Cancer Drug Gets FDA Nod for Label Expansion
Roche Holding AG’s (RHHBY - Free Report) 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 (BMY - Free Report) boasts a robust portfolio with drugs like Opdivo and Yervoy. Merck’s (MRK - Free Report) 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 (PFE - Free Report) Xalkori in patients suffering from anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Roche Holding AG Price
Roche Holding AG Price | Roche Holding AG Quote
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.
5 Trades Could Profit "Big-League" from Trump Policies
If the stocks above spark your interest, wait until you look into companies primed to make substantial gains from Washington's changing course. Today Zacks reveals 5 tickers that could benefit from new trends like streamlined drug approvals, tariffs, lower taxes, higher interest rates, and spending surges in defense and infrastructure. See these buy recommendations now >>