TESARO Announces U.S. FDA Approval of ZEJULA™ (niraparib) for Women with Recurrent Ovarian Cancer

TESARO Announces U.S. FDA Approval of ZEJULA™ (niraparib) for Women with Recurrent Ovarian Cancer

WALTHAM, MA, March 27, 2017 – TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved ZEJULA™ (niraparib), an oral, once-daily poly(ADP-ribose) polymerase (PARP) inhibitor, for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response (CR or PR) to platinum based chemotherapy. ZEJULA is the first PARP inhibitor to be approved by the FDA that does not require BRCA mutation or other biomarker testing. TESARO anticipates launching ZEJULA in the United States in late April.

TESARO Announces U.S. FDA Approval of VARUBI™ (rolapitant) for Nausea and Vomiting Associated with Cancer Chemotherapy

Waltham, Mass., Sept. 2, 2015 – TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved VARUBI™ (rolapitant) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

TESARO Announces Submission of Rolapitant New Drug Application (NDA) to U.S. Food and Drug Administration

WALTHAM, Mass., Sept. 8, 2014 (GLOBE NEWSWIRE) — TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced that it has submitted the New Drug Application (NDA) for oral rolapitant to the U.S. Food and Drug Administration (FDA). Rolapitant is an investigational neurokinin-1 (NK-1) receptor antagonist developed for the prevention of chemotherapy-induced nausea and vomiting (CINV).

 

TESARO Announces Successful Achievement of Primary and All Secondary Endpoints in Third and Final Phase 3 Trial of Rolapitant

  • Achieved Primary Endpoint of Complete Response (CR) in the Delayed Period (24 to 120 Hours) Following Initiation of Chemotherapy
  • Achieved Key Secondary Endpoints of CR in the Acute and Overall Periods
  • Achieved All Secondary Endpoints, Including No Significant Nausea
  • Adverse Event Profile Consistent with Earlier Clinical Trials
  • New Drug Application (NDA) Submission to U.S. FDA On Track for Mid-2014

WALTHAM, Mass., May 12, 2014 (GLOBE NEWSWIRE) — TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced positive top-line results from the third and final Phase 3 trial of rolapitant, an investigational neurokinin-1 (NK-1) receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting (CINV). The rolapitant arm in this trial, which enrolled patients receiving cisplatin-based, highly emetogenic chemotherapy (HEC), successfully achieved statistical significance over the standard therapy arm for the primary and all secondary endpoints. The adverse event profile for rolapitant remains consistent with that seen in previous clinical studies.

TESARO Initiates Phase 3 Trial of Niraparib for Treatment of Patients with Ovarian Cancer

 
First Patients Enrolled in the NOVA Study

WALTHAM, Mass., July 23, 2013 (GLOBE NEWSWIRE) — TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced that it has initiated patient enrollment in a Phase 3 trial of niraparib, an inhibitor of poly ADP-ribose polymerase (PARP), for the treatment of ovarian cancer. This trial, referred to as NOVA, will evaluate a single daily 300 milligram dose of niraparib in 360 patients with high grade serous, platinum sensitive, relapsed ovarian cancer compared to placebo.

TESARO Announces Presentation of Rolapitant Pharmacokinetic (PK) Data at the MASCC/ISOO International Symposium

 
PK Data from Drug-Drug Interaction Study Describes Lack of CYP3A4 Interactions

BERLIN, June 28, 2013 (GLOBE NEWSWIRE) — TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced that results from a pharmacokinetic study of rolapitant, an NK-1 receptor antagonist, were presented this morning at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) International Symposium in Berlin. These data support that rolapitant may be administered concomitantly with other pharmaceutical products that are metabolized by the liver microsomal enzyme CYP3A4, without a requirement for dose adjustment of the co-administered product. Pharmacokinetic data for other NK-1 receptor antagonists indicate that doses of concomitantly administered products metabolized by CYP3A4 must often be adjusted.

TESARO promises rapid progress with cancer drugs in $86M IPO

 
March 26, 2012

TESARO has put together an SEC filing that makes one essential promise to prospective investors interested in buying in on its $86 million IPO: This company is built for speed.

In less than a year, the developer boasts, it in-licensed rolapitant and pushed the cancer treatment into a Phase III study, with an eye to delivering top line data in the second half of next year. An IND for TSR-011 as a new therapy for non-small cell lung cancer, in-licensed from Amgen ($AMGN) in the spring of last year, is being prepped for filing in the second half. Executives–experienced veterans of MGI Pharma, which fetched close to $4 billion–are forging an accelerated pathway aimed at reducing the time it takes to reach the market. Meanwhile, more in-licensing is planned as they build out a pipeline of cancer drugs for a global marketplace. And they plan to use their connections in the cancer drug world along with substantial venture backing to make that happen.

To get to this point, TESARO has burned slightly more than $25 million from investors like NEA and Kleiner Perkins. But CEO Lonnie Moulder and his co-founders–chief scientist Mary Lynne Hedley and financial chief Rick Rogers–grabbed the industry’s attention with its ability to raise $121 million in short order. Their quick success and emphasis on speed earned a Fierce 15 award in 2011.

TESARO, though, has a set of negatives shared by everyone at this stage: No product revenue, high risk R&D work, and only a two-year track record. That’s been more than enough to chill the average investor on biotech IPOs over the past three years. Now the veteran team can see if experience and a bold timetable can warm up their prospects on Wall Street.

It should be interesting to see if their formula for success can bridge troubled market waters to a successful IPO.

FierceBiotech’s 2011 Women in Biotech – Plexxikon President and Tesaro Co-founder Honored

 
November 29, 2011

Female biotech executives have been key players in many of the biggest events in the industry this year–Takeda Pharmaceutical’s buyout of Nycomed, the merger of Alkermes ($ALKS) and Elan Drug Technologies and the sale of Plexxikon to Daiichi Sankyo. Should we be surprised? No, women in this industry defy the odds when they rise to key positions in the male-dominated biotech game. Of course we’re seeing them accomplish big things. But they deserve recognition.

So, we’re excited to bring our readers FierceBiotech’s much-awaited-and belated-Women in Biotech feature. We had an overwhelming response to our call for nominations this year, with more than 130 great submissions and an amazing slate of candidates. True to our mission of providing readers the top news in biotech, many of the honorees here are women who drove some of the big stories we covered this year. We also wanted the women featured this year to represent the best of the global biotech industry, and you’ll find women here who are making an impact for organizations based in Asia, Europe and here in the U.S.These women are inspiring, not just to women, but (at least speaking for the males on our team) men involved in the industry, too. Our profiles will bring you up to date with what each of these female movers in biotech are working on these days. Some are rallying scientists at young startups, gearing up for important late-stage trials or leading research of serious health concerns such as HIV. For each of the honorees, there are unique stories about how impressive women have gotten ahead in the competitive biotech field.”

I think that the potential interesting little extra that you get from speaking to some of the women in biotech is we’ve probably been challenged with thinking a little bit more about how to cultivate our careers,” said Abbie Celniker, chief executive of Eleven Biotherapeutics and one of this year’s Women in Biotech. “As a result, we can be a tiny bit more self-reflective because we’ve had to do lots of course correction to make sure we could compete in the days when it was more predominately male.”

Kathleen Sereda Glaub
President, Plexxikon

In the biotech business and at her home garden, Kathy Glaub likes to plant seeds and watch them grow. Of course, the seeds of biotech involve investments in R&D and carefully crafted financing strategies. In those regards, there’s been a bumper crop this year at the drug discovery firm Plexxikon, and Glaub has been able to savor the fruits of her 10 years spent helping to shape the business strategy and firming up lucrative partnership deals.

Mary Lynne Hedley
President, CSO, Co-founder, Tesaro

Mary Lynne Hedley’s latest biotech adventure has her exploring multiple paths to find and develop new therapies and supportive care drugs for cancer patients. Hedley, the president and chief scientist at Lexington, MA-based Tesaro, is now leading the company’s excursion to gain FDA approval of its lead compound, rolapitant, which aims to prevent nausea and vomiting from chemotherapy and is ready for late-stage trials. At the same time, she’s responsible for hunting for other drugs for cancer patients that fit the company’s in-licensing strategy.

Tesaro Garners $101,000,000 Series B Financing Round

 
June 21, 2011

TESARO is a privately held oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients by developing and providing safer and more effective therapeutics and supportive care products.

TESARO plans to develop one or more compounds for oncology indications, including the treatment of patients with non-small cell lung cancer (NSCLC) whose tumors express an ALK fusion protein; recent clinical proof-of-concept has been demonstrated for ALK inhibition in this patient population. The Series B financing will fund further development of these programs and expansion of the pipeline.