Bionest

Driving CAR-T beyond oncology

Several companies and research institutions are developing potential CAR-T treatments for non-cancer indications, from heart disease to viral infection.

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Long Awaited CMS Rules on Medicare Coverage for CAR-T Therapies

In August, the Centers for Medicare and Medicaid Services (CMS) finalized long-sought rules framing the coverage of chimeric antigen receptor T-cell (CAR-T) treatments. Two CAR-T therapeutics are currently on the market: Gilead’s Yescarta and Novartis’ Kymriah, both approved for diffuse large B-cell lymphoma (DLBCL) with the latter also approved for acute lymphocytic leukemia (ALL). Under...

Bionest

Bifunctional Antibodies: The Next Generation of Immuno-oncology Agents

Immuno-oncology agents, particularly checkpoint inhibitors, have moved to the forefront of cancer research and treatment in recent years. Indeed, the discovery that cancer could be treated by activating the immune system was honored with a Nobel Prize in 2018. But, as revolutionary as immuno-oncology drugs have been for the cancer field, many patients still do...

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Kite Gains First Adult CAR-T Approval

Less than two weeks following the closing of Gilead’s acquisition of the company, Kite Pharma’s CAR-T immunotherapeutic, axicabtagene ciloleucel, has gained approval from the U.S. Food and Drug Administration as the first CAR-T therapy for an adult indication. The approval, which came more than a month ahead of the expected FDA decision date, is for...

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And They’re Off….. Watching the CAR-T Race

On March 29, Novartis announced that the US Food and Drug Administration had accepted the company’s BLA filings for CTL019 (tisagenlecleucel-T) for the treatment of pediatric and young adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL). Two days later, Kite Pharma announced that they had completed the rolling submission for their own...