Roche Holdings AG (OTC:RHHBY) announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) for the label expansion of immuno-oncology drug Tecentriq.
The agency also granted Priority Review to Tecentriq plus chemotherapy (Abraxane) for the initial (first-line) treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in patients whose disease expresses the PD-L1 protein, as determined by PD-L1 biomarker testing.
The FDA is expected to make a decision on approval by Mar 12, 2019.
The sBLA is based on positive data from the phase III study, Impassion 130.
We note that Roche currently has seven ongoing phase III studies investigating Tecentriq in TNBC, including early and advanced stages of the disease. Assuming approval, this Tecentriq combination would be the first cancer immunotherapy regimen for the treatment of PD-L1-positive, metastatic TNBC.
We remind investors that Tecentriq is already approved in the European Union, the United States and more than 80 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).
A label expansion of the drug will further boost sales.
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. Growth in Herceptin is being driven by increasing demand in both the United States and Europe due to longer treatment duration. Moreover, the subcutaneous (SC) formulation of Herceptin is being increasingly adopted. The FDA approved Perjeta in combination with Herceptin and chemotherapy (the Perjeta-based regimen) for adjuvant (after surgery) treatment of HER2-positive early breast cancer (EBC) at high risk of recurrence.
Shares of Roche have gained 1.6% so far this year, against the industry’s growth of 10.8%.
Approval of new drugs and a potential label expansion of existing drugs bode well for Roche as its legacy drugs like Avastin, Herceptin and MabThera are facing competition from biosimilars. Novartis (NYSE:NVS) has already launched its biosimilar version of Rituxan/ MabThera in Europe. Amgen (NASDAQ:AMGN) too has got its biosimilar of Avastin.
Zacks Rank & Stock to Consider
Roche currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Gilead Sciences Inc. (NASDAQ:GILD) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates increased from $6.58 to $6.87 for 2018 over the past 60 days. Estimates for 2019 are also up by 27 cents.
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Novartis AG (NVS): Free Stock Analysis Report
Roche Holding (SIX:ROG
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