TSRO ZEJULA/Niraparib Approval + Niraparib Update
Mar 28, 2017 6:31:43 GMT
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Post by tomsylver on Mar 28, 2017 6:31:43 GMT
Slides:
ir.tesarobio.com/common/download/download.cfm?companyid=AMDA-Z6KN1&fileid=934883&filekey=2AA65641-CA11-459D-A283-10A93E1B53A2&filename=Zejula_Approval_and_Dev_Update_032717.pdf
TESARO ANNOUNCES U.S. FDA APPROVAL OF ZEJULA™ (NIRAPARIB) FOR WOMEN WITH RECURRENT OVARIAN CANCER
* ZEJULA is the first and only PARP inhibitor to be approved for the maintenance treatment of women with recurrent ovarian cancer
* Use of ZEJULA does not require patient selection with a biomarker test
* U.S. commercial launch planned for late April
* Investor conference call and webcast to be held at 4:30 PM ET today
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.
Multimedia materials accompanying this release are available at: www.multivu.com/players/English/8050551-tesaro-zejula-niraparib-fda-approval/.
ZEJULA is the only PARP inhibitor that has demonstrated 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 3 clinical trial. ZEJULA offers oral, once-daily dosing, enabling convenient administration for maintenance treatment. FDA approval of ZEJULA is based upon data from the international Phase 3 ENGOT-OV16/NOVA trial, a double-blind, placebo-controlled study 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. Progression in the NOVA study was determined by robust, unbiased, blinded central review, to be the earlier of radiographic or clinical progression. ZEJULA significantly increased PFS in patients with and without germline BRCA mutations as compared to control. Treatment with ZEJULA reduced the risk of disease progression or death by 74% in patients with germline BRCA mutations (HR 0.26) and by 55% in patients without germline BRCA mutations (HR 0.45). The magnitude of benefit was similar for patients entering the trial with a PR or a CR.
The most common grade 3/4 adverse reactions to ZEJULA in the NOVA trial included thrombocytopenia (29%), anemia (25%), neutropenia (20%), and hypertension (9%). The majority of hematologic adverse events were successfully managed via dose modification, and discontinuation of therapy due to thrombocytopenia, neutropenia and anemia occurred in 3.3%, 1.9% and 1.4% of patients, respectively. Following dose adjustment based on individual tolerability, the incidence of grade 3/4 thrombocytopenia was low; approximately <1% after month 2. Please see the “Select Important Safety Information” below for warnings, precautions and adverse events.
ir.tesarobio.com/common/download/download.cfm?companyid=AMDA-Z6KN1&fileid=934883&filekey=2AA65641-CA11-459D-A283-10A93E1B53A2&filename=Zejula_Approval_and_Dev_Update_032717.pdf
TESARO ANNOUNCES U.S. FDA APPROVAL OF ZEJULA™ (NIRAPARIB) FOR WOMEN WITH RECURRENT OVARIAN CANCER
* ZEJULA is the first and only PARP inhibitor to be approved for the maintenance treatment of women with recurrent ovarian cancer
* Use of ZEJULA does not require patient selection with a biomarker test
* U.S. commercial launch planned for late April
* Investor conference call and webcast to be held at 4:30 PM ET today
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.
Multimedia materials accompanying this release are available at: www.multivu.com/players/English/8050551-tesaro-zejula-niraparib-fda-approval/.
ZEJULA is the only PARP inhibitor that has demonstrated 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 3 clinical trial. ZEJULA offers oral, once-daily dosing, enabling convenient administration for maintenance treatment. FDA approval of ZEJULA is based upon data from the international Phase 3 ENGOT-OV16/NOVA trial, a double-blind, placebo-controlled study 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. Progression in the NOVA study was determined by robust, unbiased, blinded central review, to be the earlier of radiographic or clinical progression. ZEJULA significantly increased PFS in patients with and without germline BRCA mutations as compared to control. Treatment with ZEJULA reduced the risk of disease progression or death by 74% in patients with germline BRCA mutations (HR 0.26) and by 55% in patients without germline BRCA mutations (HR 0.45). The magnitude of benefit was similar for patients entering the trial with a PR or a CR.
The most common grade 3/4 adverse reactions to ZEJULA in the NOVA trial included thrombocytopenia (29%), anemia (25%), neutropenia (20%), and hypertension (9%). The majority of hematologic adverse events were successfully managed via dose modification, and discontinuation of therapy due to thrombocytopenia, neutropenia and anemia occurred in 3.3%, 1.9% and 1.4% of patients, respectively. Following dose adjustment based on individual tolerability, the incidence of grade 3/4 thrombocytopenia was low; approximately <1% after month 2. Please see the “Select Important Safety Information” below for warnings, precautions and adverse events.
