Roche Gets Priority Review for Immunotherapy Drug Tecentriq
Roche Holding AG’s RHHBY Genentech announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for cancer immunotherapy, Tecentriq, for the treatment of patients suffering from locally advanced or metastatic urothelial carcinoma (mUC) who are ineligible for cisplatin chemotherapy, and are either treatment naive or have disease progression at least 12 months after receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant).
Notably, Roche has underperformed the Zacks classified Large Cap Pharmaceuticals industry in the last 12 months. In fact, the stock lost 8.3% in the last 12 months, compared with a drop of 1.7% for the industry.
Coming back to the latest news, we note that Tecentriq is approved in the U.S. for treating advanced bladder cancer patients. As per the press release, urothelial carcinoma accounts for 90% of all bladder cancers and can be found in the renal pelvis, ureter and urethra.
A decision from the FDA is expected by Apr 30, 2017. We remind investors that the FDA generally grants priority review to medicines that have the potential to provide significant improvements in the safety and effectiveness for the treatment, prevention or diagnosis of a serious disease.
In Oct 2016, 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). Label expansion should boost the drug’s sales further.
However, competition is stiff in the immunotherapy space with players like Bristol-Myers Squibb BMY which boasts a robust portfolio with drugs like Opdivo and Yervoy. Merck’s MRK Keytruda also poses strong competition with approvals for a varied range of cancers.
Roche currently carries a Zacks Rank #4 (Sell). Roche has been investing significant resources in personalized cancer immunotherapy with more than 20 pipeline candidates. Roche has a strong presence in the oncology market. In particular, the company dominates the breast cancer space with strong demand for its HER2 franchise drugs. The HER2 franchise includes Herceptin, Perjeta and Kadcyla. Approval of new drugs and therapies is critical for Roche at this juncture as the company has been facing stiff generic competition for some of its drugs like Pegasys, Xeloda and Valcyte. In addition, possibility of stiff competition from biosimilars looms large on some of Roche’s key drugs such as Avastin, Rituxan and Herceptin over the long term. The biosimilar versions of MabThera and Herceptin are expected to enter the market soon.
Roche Holding AG Price and Consensus
Roche Holding AG Price and Consensus | Roche Holding AG Quote
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