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.Tesaro Announces Priority Review Designation for Niraparib NDA

Niraparib New Drug Application accepted for review by FDA with a PDUFA goal date of June 30, 2017
Niraparib Expanded Access Program (EAP) expected to open in U.S. in January 2017
WALTHAM, Mass., Dec. 20, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the niraparib New Drug Application (NDA). Niraparib is a PARP inhibitor that is being evaluated as a potential new treatment option for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following response to platinum-based chemotherapy. The FDA has established a target action date under the Prescription Drug User Fee Act (PDUFA) of June 30, 2017, and is not currently planning to hold an advisory committee meeting to discuss this application.

Priority Review status is given to drugs that might offer significant improvements in treatment or provide a treatment where no adequate therapy exists.

The niraparib NDA is supported by data from the ENGOT-OV16/NOVA trial, a double-blind, placebo-controlled, international Phase 3 study that enrolled 553 patients with recurrent ovarian cancer who had achieved either a partial response (PR) or a complete response (CR) to their most recent platinum-based chemotherapy. This trial was designed to assess progression free survival (PFS) in patients who were assigned to one of two cohorts based upon germline BRCA mutation status. The full results of the ENGOT-OV16/NOVA trial were presented in detail at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen on October 8, 2016 and were published simultaneously in The New England Journal of Medicine.

"FDA's acceptance of the niraparib NDA with a Priority Review designation is an important milestone for TESARO, and represents a significant step in our efforts to bring meaningful therapies to women with ovarian cancer," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "We believe niraparib could become an important new treatment option for patients with recurrent ovarian cancer, and we look forward to working with the FDA during the review process."

The ENGOT-OV16/NOVA trial successfully achieved its primary endpoint in both patient cohorts, demonstrating that niraparib treatment significantly prolonged PFS compared to control. Among patients who were germline BRCA mutation carriers, the niraparib arm successfully achieved statistical significance over the control arm for the primary endpoint of PFS, with a hazard ratio of 0.27 (95% CI, 0.173-0.410). The median PFS for patients treated with niraparib was 21.0 months, compared to 5.5 months for control (p<0.0001). Among patients in the non-germline BRCA mutant cohort, the niraparib arm successfully achieved statistical significance over the control arm for the primary endpoint of PFS, with a hazard ratio of 0.45 (95% CI, 0.338-0.607). The median PFS for patients treated with niraparib was 9.3 months, compared to 3.9 months for control (p<0.0001). Based upon the results of this trial, the indication proposed in the NDA provides for the use of niraparib regardless of tumor biomarker status, and it is anticipated that the BRACAnalysis® CDx and myChoice® HRD tests would be available to physicians as complementary diagnostics.

The most common (≥10%) treatment-emergent grade 3/4 adverse events in the niraparib arm were thrombocytopenia (33.8%), anemia (25.3%), and neutropenia (19.6%) with treatment discontinuation for these events of 3.3%, 1.4% and 1.9%, respectively. Thrombocytopenia was not associated with grade 3/4 bleeding events. The majority of these hematological laboratory abnormalities occurred within the first three cycles; following dose modifications based on individual patient tolerability, the incidence of these lab abnormalities decreased and thrombocytopenia and neutropenia were infrequent beyond cycle 3. The rates of MDS/AML in the niraparib (1.4%) and control (1.1%) arms were similar. There were no deaths among patients during study treatment.

An Expanded Access Program (EAP) for niraparib in the United States is planned to open in January 2017. Expanded access programs enable patients with serious or life-threatening illnesses who do not otherwise qualify for participation in a clinical trial and for whom there are no comparable or satisfactory alternate therapies to access investigational medicines. Through the program, niraparib will be made available for patients with recurrent ovarian cancer following response to platinum-based chemotherapy.

About Niraparib
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in three pivotal trials. TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes a Phase 3 trial in patients with first-line ovarian cancer (the PRIMA trial), a Phase 3 trial for the treatment of patients with germline BRCA-mutated, metastatic breast cancer (the BRAVO trial), and a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial). Several combination studies are also underway, including trials of niraparib plus pembrolizumab in metastatic, triple-negative breast cancer and advanced, platinum-resistant ovarian cancer (the TOPACIO trial) and niraparib plus bevacizumab in recurrent, platinum-sensitive ovarian cancer (the ENGOT-OV24/AVANOVA trial). Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.

In September 2016, the FDA granted Fast Track designation to niraparib. The FDA Fast Track designation is designed to facilitate the development and expedite the review of medicines that are intended to treat serious conditions and address unmet medical needs. As part of the Fast Track program, the FDA allows for the submission of completed portions of an NDA on an ongoing or rolling basis.

Niraparib is an investigational agent and, as such, has not been approved by the U.S. FDA, European Medicines Agency (EMA), or any other regulatory agencies.
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Source: press release, 12/20/16. http://ir.tesarobio.com/releasedetail.cfm?ReleaseID=1004986

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TESARO ANNOUNCES SUBMISSION OF NIRAPARIB NEW DRUG APPLICATION FOR PLATINUM-SENSITIVE, RECURRENT OVARIAN CANCER

WALTHAM, Mass., Nov. 01, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that it has completed the niraparib rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for the maintenance treatment of patients with platinum-sensitive, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based chemotherapy.

The niraparib NDA is supported by data from the ENGOT-OV16/NOVA trial, a double-blind, placebo-controlled, international Phase 3 study that enrolled 553 patients with recurrent ovarian cancer who were in response to their most recent platinum-based chemotherapy. This trial was designed to assess progression free survival (PFS) in patients who were assigned to one of two cohorts based upon germline BRCA mutation status, as determined by the Myriad BRACAnalysis CDx® test. Within the cohort of patients who were not germline BRCA mutation carriers (non-gBRCAmut), tumor samples were assessed for HRD status using the Myriad myChoice® HRD test.

The ENGOT-OV16/NOVA trial successfully achieved its primary endpoint in both patient cohorts, demonstrating that niraparib treatment significantly prolonged PFS compared to control. The full results of the ENGOT-OV16/NOVA trial were presented in detail at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen on October 8, 2016 and were published simultaneously in The New England Journal of Medicine. Based upon the results of this trial, the indication proposed in the NDA provides for the use of niraparib regardless of tumor biomarker status, and it is anticipated that the BRACAnalysis® CDx and myChoice® HRD tests would be available to physicians as complementary diagnostics.

"TESARO is working daily to benefit the many women living with ovarian cancer," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "Our niraparib NDA and MAA submissions represent a significant step in our efforts to bring meaningful therapies to these patients."
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Source: press release, 11/01/16. http://ir.tesarobio.com/releasedetail.cfm?ReleaseID=996821

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TESARO RECEIVES FDA FAST TRACK DESIGNATION FOR NIRAPARIB AND INITIATES ROLLING NDA SUBMISSION

WALTHAM, Mass., Sept. 12, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to niraparib for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. TESARO has initiated a rolling submission of a New Drug Application (NDA) for niraparib to the FDA, and intends to complete this submission during the fourth quarter. The Marketing Authorization Application (MAA) for niraparib is planned for submission to the European Medicines Agency (EMA) in the fourth quarter.

The FDA Fast Track designation is designed to facilitate the development and expedite the review of medicines that are intended to treat serious conditions and address unmet medical needs. As part of the Fast Track program, the FDA allows for the submission of completed portions of an NDA on an ongoing or rolling basis.

"The initiation of this rolling NDA submission is a significant milestone for TESARO, and we are committed to working collaboratively with the FDA to advance the review of the niraparib application," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "We look forward to presentation of data from the Phase 3 NOVA trial of niraparib in a Presidential Symposium session at the European Society for Medical Oncology (ESMO) congress on October 8."

NOVA is a double-blind, placebo-controlled, international Phase 3 trial of niraparib that enrolled more than 500 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy.
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Source: press release, 9/12/16. http://ir.tesarobio.com/releasedetail.cfm?ReleaseID=988681

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Niraparib (MK-4827) Ovarian cancer OncologyOvarian CancerPARP inhibitorPARP

Mechanism of action: Niraparib (MK-4827) is an inhibitor of poly (ADP-ribose) polymerase (PARP) with potential antineoplastic activity. Niraparib inhibits PARP activity, enhancing the accumulation of DNA strand breaks and promoting genomic instability and apoptosis. The PARP family of proteins detect and repair single strand DNA breaks by the base-excision repair (BER) pathway. The specific PARP family member target for Niraparib is unknown.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2017-06-30

Results: Pending