Roche Holding AG (RHHBY - Free Report) announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) for and granted Priority Review to Tecentriq (atezolizumab) in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). The FDA is expected to make a decision by Mar 18, 2019.
Priority Review designation from the FDA is generally granted to drugs with potential to provide significant improvements in the safety and effectiveness of the treatment plus prevention or diagnosis of a serious disease.
We note that Tecentriq is already approved in the United States and European Union for patients with previously-treated metastatic NSCLC and for patients with locally advanced or metastatic urothelial cancer (mUC) who are not eligible for cisplatin chemotherapy or who have had disease progression during or following platinum-containing therapy.
This sBLA is based on results from the phase III IMpower133 study that met its overall survival (OS) and progression-free survival (PFS)co-primary endpoints, per the study protocol. The results of the study showed that initial (first-line) treatment with the combination of Tecentriq and chemotherapy (carboplatin and etoposide) enabled patients with ES-SCLC live significantly longer compared to chemotherapy alone. The combination also reduced the risk of disease worsening or death (PFS) compared to chemotherapy alone.
Roche’s stock has gained 4.4% so far this year compared with the industry's growth of 12.6%.
Approval of new drugs and a potential label expansion of existing drugs bode well for Roche, as its legacy drugs like Herceptin and MabThera are facing competition from biosimilars.
Novartis (NVS - Free Report) has already launched its biosimilar version of Rituxan/MabThera in Europe. Amgen (AMGN - Free Report) obtained FDA approval for a biosimilar version of Avastin for the treatment of five types of cancers, including lung cancer, colorectal cancer, glioblastoma, renal cell carcinoma and cervix cancer.
Zacks Rank and Stock to Consider
Roche currently carries a Zacks Rank #3 (Hold).
A better-ranked stock worth considering is Bristol-Myers Squibb Company (BMY - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings per share estimates have increased from $3.63 to $3.87 for 2018 and $3.92 to $4.08 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 11.99%.
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