Roche (RHHBY - Free Report) announced that the FDA has accepted the company’s Biologics License Application (BLA) for anti-CD79b antibody drug conjugate (ADC) polatuzumab vedotin in combination with bendamustine plus Rituxan (BR), for the treatment of patients suffering from relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), and granted Priority Review status to the same.
A decision from the FDA is expected by Aug 19, 2019.
We note that Priority Review designation is granted to drugs that have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease.
Polatuzumab vedotin was earlier granted Breakthrough Therapy designation by the FDA and PRIME (PRIority MEdicines) designation by the European Medicines Agency for the treatment of patients with R/R DLBCL in 2017. Polatuzumab vedotin is being evaluated for the treatment of several types of non-Hodgkin lymphoma (NHL).
A potential approval will boost Roche’s hematology portfolio, which comprises approved drugs like MabThera/Rituxan, Tecentriq, Gazyva and Venclexta in collaboration with AbbVie (ABBV - Free Report) .
The pipeline includes polatuzumab vedotin and a small molecule that inhibits the interaction of MDM2 with p53 (idasanutlin/RG7388). The company also has Hemlibra in its portfolio, a bispecific monoclonal antibody for the treatment of haemophilia A.
Concurrently, the FDA accepted the company’s New Drug Applications (NDAs) and granted Priority Review status to pipeline candidate entrectinib. The candidate is being evaluated for the treatment of adult and pediatric patients with neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive, locally advanced or metastatic solid tumors who have either progressed following prior therapies or as an initial therapy when there are no acceptable standard therapies, and for the treatment of people with metastatic, ROS1-positive non-small cell lung cancer (NSCLC). A decision from the FDA is expected by Aug 18, 2019.
The candidate is being developed across a range of solid tumor types, including breast, cholangiocarcinoma, colorectal, gynaecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.
Roche’s stock has gained 12.6% in the last six months compared with the industry's growth of 2.5%.
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 bisomilar version of Rituxan/ MabThera in Europe. Amgen (AMGN - Free Report) also obtained FDA approval for a biosimilar version of Avastin for the treatment of five types of cancers including lung, colorectal, glioblastoma, renal cell carcinoma and cervix. Entry of biosimilars of these key drugs adversely impacted sales in Europe in 2018.
Roche currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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