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Tesaro Wins FDA Approval for Ovarian Cancer Drug Zejula
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Tesaro, Inc. recently announced that the FDA has approved its oral, once-daily poly(ADP-ribose) polymerase (PARP) inhibitor Zejula (niraparib)for the maintenance treatment of women suffering from recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response (CR or PR) to platinum-based chemotherapy.
A look at Tesaro’s share price movement in the past one year shows that the company has outperformed the Medical Drugs industry. While the stock rallied a whopping 238.4%, the industry registered a gain of 14.3%.
The approval comes earlier than expected. The company submitted an NDA for Zejula in Oct 2016 and the FDA had granted a priority review designation with a target Prescription Drug User Fee Act (PDUFA) action date of Jun 30, 2017.
We note that Zejula is the first PARP inhibitor to be approved by the FDA that does not require BRCA mutation or other biomarker testing. The approval was based upon data from the international phase III trial, ENGOT-OV16/NOVA that enrolled 553 patients with recurrent ovarian cancer who had achieved either a PR or CR to their most recent platinum-based chemotherapy. Approximately two-thirds of study participants did not have germline BRCA mutations.
The company anticipates launching Zejula in the U.S. in late April. A Marketing Authorisation Application for the drug is under review by the European Medicines Agency (EMA).
The drug showed a clinically meaningful increase in progression-free survival (PFS) in women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status, in a randomized, prospectively designed phase III trial.
Approximately 22,000 women are diagnosed with ovarian cancer each year in the U.S. and more than 65,000 women are diagnosed annually in Europe.
We note that AstraZeneca’s (AZN - Free Report) Lynparza is another PARP inhibitor which is approved for the treatment of women with advanced ovarian cancer who have received previous treatment with three or more prior chemotherapy medicines or a combination of chemotherapy medicines for their cancer and have a certain type of abnormal inherited BRCA gene. Clovis Oncology’s Rubraca is also approved for the same indication.
Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 30 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 291.54%.
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Tesaro Wins FDA Approval for Ovarian Cancer Drug Zejula
Tesaro, Inc. recently announced that the FDA has approved its oral, once-daily poly(ADP-ribose) polymerase (PARP) inhibitor Zejula (niraparib)for the maintenance treatment of women suffering from recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response (CR or PR) to platinum-based chemotherapy.
A look at Tesaro’s share price movement in the past one year shows that the company has outperformed the Medical Drugs industry. While the stock rallied a whopping 238.4%, the industry registered a gain of 14.3%.
The approval comes earlier than expected. The company submitted an NDA for Zejula in Oct 2016 and the FDA had granted a priority review designation with a target Prescription Drug User Fee Act (PDUFA) action date of Jun 30, 2017.
We note that Zejula is the first PARP inhibitor to be approved by the FDA that does not require BRCA mutation or other biomarker testing. The approval was based upon data from the international phase III trial, ENGOT-OV16/NOVA that enrolled 553 patients with recurrent ovarian cancer who had achieved either a PR or CR to their most recent platinum-based chemotherapy. Approximately two-thirds of study participants did not have germline BRCA mutations.
The company anticipates launching Zejula in the U.S. in late April. A Marketing Authorisation Application for the drug is under review by the European Medicines Agency (EMA).
The drug showed a clinically meaningful increase in progression-free survival (PFS) in women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status, in a randomized, prospectively designed phase III trial.
Approximately 22,000 women are diagnosed with ovarian cancer each year in the U.S. and more than 65,000 women are diagnosed annually in Europe.
We note that AstraZeneca’s (AZN - Free Report) Lynparza is another PARP inhibitor which is approved for the treatment of women with advanced ovarian cancer who have received previous treatment with three or more prior chemotherapy medicines or a combination of chemotherapy medicines for their cancer and have a certain type of abnormal inherited BRCA gene. Clovis Oncology’s Rubraca is also approved for the same indication.
Zacks Rank & Stocks to Consider
Tesaro currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the health care sector is Heska Corporation . The stock carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 30 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 291.54%.
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 >>