New FDA Approvals: FDA Gives Accelerated Approval to J&J’s Talvey
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Sep 14, 2023
Aug. 9: The FDA gave accelerated approval to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Talvey (talquetamab-tgvs) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. The review was conducted under Project Orbis in collaboration with the Australian Therapeutic Goods Administration and Switzerland’s Swissmedic; it used the Assessment Aid. The agent, a G protein-coupled receptor class C group 5 member D (GPRC5D)-directed CD3 T-cell engager, is a first-in-class bispecific antibody. Dosing of the subcutaneous injection, which is administered by a qualified health care professional, can be done weekly or biweekly. For weekly dosing, a step-up schedule consists of 0.01 mg/kg on day one, then 0.06 mg/kg on day four, then 0.4 mg/kg on day seven and then 0.4 mg/kg one week later and weekly thereafter. For biweekly dosing, administration starts at 0.01 mg/kg on day one, 0.06 mg/kg on day four, 0.4 mg/kg on day seven, then 0.8 mg/kg on day 10 and then 0.8 mg/kg two weeks later and every two weeks thereafter. The drug’s list price is $45,000 per month, and the company estimates a pricing range of $270,000 to $360,000 for an average treatment duration of six to eight months. Read more
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