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BMS’ long-standing leukemia blockbuster stares down its first generic

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Bristol Myers Squibb could soon see some headwinds for its blockbuster leukemia drug Sprycel as the first generic is expected to hit the market in September.

Source
Pharma Voice

Xspray, seeking FDA approval for its Sprycel competitor, settles patent lawsuit with BMS

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Xspray Pharma, before receiving an FDA slapdown in July, had expected to launch its competitor to Bristol Myers Squibb’s leukemia blockbuster Sprycel within the second half of 2023. But as the company works to patch up dosing and manufacturing issues on its lead candidate—dubbed Dasynoc—Xspray has resolved another potential hurdle for its product.

Source
Fierce Pharma

FDA rejects Xspray's would-be rival to Bristol Myers' Sprycel on dosing, manufacturing concerns

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With Xspray Pharma and Eversana’s cancer med hitting a regulatory setback, a launch in the second half of 2023 now looks unlikely. That’s good news for Bristol Myers Squibb, which has secured a few more competition-free months for its aging leukemia blockbuster Sprycel.

Source
Fierce Pharma

Using Bristol-Myers’ popular leukemia drug to improve anti-PD-1 cancer immunotherapy

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Anti-PD-1/L1 therapies, which remove "checkpoints" that prevent the immune system from fighting cancer, have been hailed as a major treatment advance. But not all patients respond to checkpoint inhibitors. Researchers are exploring new ways to improve their efficacy, and a team led by Cedars-Sinai Medical Center has pinpointed a popular blood cancer drug by Bristol-Myers Squibb as a potential booster.

Source
Fierce Biotech

New Class of Breast Cancer Drugs Could Help Treat Toughest Lung Cancer Cases

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Researchers with the Francis Crick Institute- and The Institute of Cancer Research recently published research suggesting that a new class of drugs that is helpful in treating breast cancers could help treat some of the hardest-to-treat lung cancers. They published their work in the journal Cell Reports.

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BioSpace

The FDA Accepts Bristol-Myers Squibb’s Application for Sprycel in Ph+ Acute Lymphoblastic Leukemia

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Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental Biologics License Application (sBLA) for Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). The FDA action date is December 29, 2018.

Source
CP Wire

The FDA Accepts Bristol-Myers Squibb’s Application for Sprycel in Ph+ Acute Lymphoblastic Leukemia


Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental Biologics License Application (sBLA) for Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). The FDA action date is December 29, 2018.