Roche's (RHHBY) BLA For Lymphoma Drug Gets Priority Review
Zacks Investment Research | Feb 19, 2019 04:41AM ET
Roche (OTC:RHHBY) 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 (NYSE:ABBV) .
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%.
Get The News You Want
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 (NYSE:NVS) has already launched its bisomilar version of Rituxan/ MabThera in Europe. Amgen (NASDAQ:AMGN) 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.
Zacks Rank
Roche currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .
Is Your Investment Advisor Fumbling Your Financial Future?
See how you can more effectively safeguard your retirement with a new Special Report, “4 Warning Signs Your Investment Advisor Might Be Sabotaging Your Financial Future."
Zacks Investment Research
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.