Roche (OTC:RHHBY) announced that the European Commission (EC) granted conditional marketing authorization to oncology drug, Polivy.
Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC).
The EC approved Polivy (polatuzumab vedotin) in combination with bendamustine plus MabThera (rituximab) (BR) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who are not candidates for a hematopoietic stem cell transplant.
The conditional approval is based on the results from the phase Ib/II GO29365 study. The study data showed that 40% of people treated with Polivy plus BR achieved a complete response compared to 17.5% with BR alone.
Conditional approval is granted to drugs that fulfill unmet medical needs, where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required.
In June 2019, the drug in combination with BR was also granted accelerated approval by the FDA for the treatment of patients with R/R DLBCL, who have received at least two prior therapies. The drug was granted Breakthrough Therapy designation by the FDA and PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA) for the treatment of people with R/R DLBCL in 2017.
Polivy was developed by Roche using Seattle Genetics’ (NASDAQ:SGEN) ADC technology and is currently being investigated for the treatment of non-Hodgkin lymphoma (NHL).
The stock has gained 31.7% in the past year compared with the industry's 15.1% growth.
The approval of Polivy will strengthen Roche’s hematology portfolio, which comprises approved drugs like MabThera/Rituxan, Tecentriq, Gazyva and Venclexta, in collaboration with AbbVie (NYSE:ABBV) . The company also has Hemlibra in its portfolio for the treatment of hemophilia A.
Roche is currently looking to diversify its portfolio in wake of stiff competition from biosimilars for key drugs such as Avastin, Rituxan and Herceptin from Novartis and Amgen (NASDAQ:AMGN) .
The stock currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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