We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Roche's (RHHBY) Lymphoma Drug Polivy Gets Approval in Europe
Read MoreHide Full Article
Roche (RHHBY - Free Report) 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’ 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 (ABBV - Free Report) . 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 (AMGN - Free Report) .
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Image: Bigstock
Roche's (RHHBY) Lymphoma Drug Polivy Gets Approval in Europe
Roche (RHHBY - Free Report) 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’ 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 (ABBV - Free Report) . 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 (AMGN - Free Report) .
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.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Click here for the 6 trades >>