Astra and Merck Win Speedy Review for Lynparza in Breast Cancer

Excerpt:

“U.S. regulators have granted a priority review to AstraZeneca’s ovarian cancer drug Lynparza as a treatment for breast cancer, putting it on track for potential approval in the new disease area during the first quarter of 2018.

“The medicine, which is being jointly developed and marketed with Merck under a deal struck in July, is the first poly ADP-ribose polymerase (PARP) drug to be considered for use outside ovarian cancer.”

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FDA Grants Priority Review to Opdivo for Resected, High-Risk Melanoma

Excerpt:

“The FDA granted priority review to nivolumab for the treatment of patients with melanoma who are at high risk for disease recurrence following complete surgical resection, according to the drug’s manufacturer.

“Nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 checkpoint inhibitor, previously received breakthrough therapy designation for this indication.”

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US FDA Accepts Supplemental Biologics License Application for Imfinzi in Locally Advanced Unresectable Non-Small Cell Lung Cancer

Excerpt:

“AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) for the treatment of patients with locally advanced (Stage III) unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. The FDA has granted Imfinzi Priority Review status.”

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FDA Grants Priority Review to Frontline Abemaciclib for HR+/HER2- Advanced Breast Cancer

Excerpt:

“The FDA has granted a priority review to a new drug application (NDA) for abemaciclib (Verzenio) for use in combination with an aromatase inhibitor for the frontline treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer, according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor.

“The NDA was based on data from the phase III MONARCH 3 trial in which the addition of abemaciclib to anastrozole or letrozole reduced the risk of progression or death by 46% compared with the nonsteroidal aromatase inhibitor (NSAI) alone for previously untreated patients with HER2-negative, HR-positive advanced breast cancer.”

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FDA Grants Priority Review to Afatinib for NSCLC With Rare EGFR Mutations

Excerpt:

“The FDA has granted a priority review to a supplemental new drug application (sNDA) for afatinib (Gilotrif) for the frontline treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors harbor EGFR exon 21 (L861Q), G719X, or S768I substitution mutations.

“Uncommon mutations such as these represent less than 10% of the EGFR mutations found in NSCLC patients, but are associated with poor prognosis and survival, Boehringer Ingelheim, the manufacturer of afatinib, noted in a press release.”

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FDA Grants Genentech’s Alecensa Priority Review for Initial Treatment of People with ALK-Positive Lung Cancer

Excerpt:

“Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Alecensa® (alectinib) as an initial (first-line) treatment for people with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. The FDA will make a decision on approval by November 30, 2017.

” ‘Phase III results showed Alecensa reduced the risk of disease worsening by more than half compared to the current standard of care and lowered the risk of tumors spreading to or growing in the brain by more than 80 percent,’ said Sandra Horning, M.D., chief medical officer and head of Global Product Development. ‘We are working closely with the FDA to bring this medicine as an initial treatment for people with ALK-positive NSCLC as soon as possible.’ ”

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FDA Grants Ceritinib Priority Review in Frontline ALK+ NSCLC

Excerpt:

“The FDA has granted a priority review to ceritinib (Zykadia) as a first-line treatment for patients with ALK-positive, metastatic non–small cell lung cancer (NSCLC), according to Novartis, the manufacturer of the second-generation ALK inhibitor.

“The priority review is based on findings from the phase III ASCEND-4 trial, in which ceritinib reduced the risk of disease progression or death by 45% compared with standard chemotherapy. The median progression-free survival (PFS) benefit favoring ceritinib was 8.5 months (HR, 0.55; 95% CI, 0.42-0.73; P <.001).”

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FDA Grants Brigatinib Priority Review for ALK-Positive NSCLC

Excerpt:

“The FDA has has granted a priority review to a new drug application (NDA) for brigatinib for patients with metastatic ALK-positive non–small cell lung cancer (NSCLC) who are resistant to prior crizotinib (Xalkori), according to a statement from the drug’s developer, Ariad Pharmaceuticals.

“The NDA, which follows a breakthrough therapy designation that was received in October 2014, is based on findings from the phase II ALTA trial. In results from the trial presented at the 2016 ASCO Annual Meeting, the confirmed objective response rate (ORR) for brigatinib at 180 mg daily was 54% and the median progression-free survival (PFS) was 12.9 months. Under the Prescription Drug User Fee Act, the FDA is scheduled to make a final decision on the NDA by April 29, 2017.”

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FDA Gives Ribociclib Priority Review for Frontline HR+/HER2- Breast Cancer

Excerpt:

“The FDA has granted priority review designation to a new drug application (NDA) for ribociclib (LEE011) for use in combination with letrozole as a frontline therapy for patients with hormone-receptor (HR)–positive, HER2-negative advanced breast cancer.

“The NDA for the CDK 4/6 inhibitor is primarily based on findings from the phase III MONALEESA-2 trial, in which combining ribociclib with letrozole reduced the risk of progression or death by 44% compared with letrozole alone in the first-line setting for HR+/HER2- advanced breast cancer (HR, 0.556; 95% CI, 0.43-0.72; P = .00000329). Under the priority designation, the NDA will be reviewed within 6 months, compared with the standard 10-month review.”

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