FDA approves Sage Therapeutics’ rapid

In cancer immunotherapy these days, technology is advancing so fast that 2017’s buzzy new treatment may soon be passe: Only 18 months after approval of the first CAR-T, pharmaceutical companies and biotechs are already talking about next-generation cancer therapy.

Called bispecific antibodies, they’re being developed by some two dozen companies large and small, with a version cleverly branded as BiTEs already constituting 60 percent of Amgen’s oncology pipeline. The appeal: Bispecifics make the immune system kill tumor cells like first-gen immunotherapy, but, unlike the weeks it takes to laboriously manufacture CAR-Ts, they can start being infused almost as quickly as an oncologist can write a prescription.

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“We’re very bullish” on BiTEs, said Dr. David Reese, head of R&D at Amgen, which has the only cancer-targeting bispecific approved for clinical use in the U.S. and 14 more in development, including for multiple myeloma, small cell lung cancer, glioblastoma, and other solid tumors. “We can generate a BiTE against any tumor antigen we want to go after.”

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