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TESARO ANNOUNCES FIRST-QUARTER 2017 OPERATING RESULTS
· ZEJULA approved by U.S. FDA for the maintenance treatment of women with recurrent ovarian cancer, regardless of BRCA or biomarker status; commercial launch underway
· ZEJULA added to the NCCN Clinical Practice Guidelines in Oncology
· Expanded development program for niraparib in ovarian, lung and breast cancers to begin 2H 2017
· VARUBY® approved in Europe and launches to begin late 2Q 2017
· VARUBI® IV NDA re-submitted to FDA; approval anticipated late 2Q 2017
· TSR-042 clinical program now open to enroll patients with MSI-H endometrial cancer
· TSR-022 (anti-TIM-3) combination trial with TSR-042 expected to initiate mid-2017
WALTHAM, Mass., May 9, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today reported operating results for first-quarter 2017 and provided an update on the Companys commercial products and development programs.
The recent FDA approval and U.S. launch of ZEJULA represents a significant advancement for patients with recurrent ovarian cancer and marked a key milestone for the Company, said Lonnie Moulder, CEO of TESARO. TESARO is committed to supporting people bravely facing cancer, and we are very gratified by the early positive feedback we have received from physicians and patients as they begin to utilize ZEJULA. The unprecedented results of the NOVA trial support our view of ZEJULA as the foundation of a broad franchise opportunity with potential applications across a variety of tumor types, as both a monotherapy and in combination, and we will be advancing multiple new clinical trials of niraparib in metastatic ovarian, breast and lung cancers. Following the recent approval of VARUBY by the European Commission, we are preparing to globalize our mission and bring this important product to patients in Europe beginning in June. Our immuno-oncology programs continue to rapidly advance, and we look forward to reporting initial data from our trials this year.
Recent Business Highlights
· The U.S. launch of ZEJULA is off to a strong start, with approximately 500 prescriptions written since approval. TESARO launched ZEJULA in late April, following U.S. Food and Drug Administration (FDA) approval for use as a 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 patient selection with a biomarker test.
· The National Comprehensive Cancer Network (NCCN) recently added ZEJULA to the NCCN Clinical Practice Guidelines in Oncology Ovarian Cancer version 1.2017April 12, 2017as maintenance therapy for patients with platinum-sensitive disease who are in partial or complete response after completion of two or more lines of platinum-based therapy.
The following information was filed by Tesaro, Inc. (TSRO) on Tuesday, May 9, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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