How J&J navigated regulatory approval for a Drug to Watch

The emerging field of bispecific antibodies presents tremendous promise to cancer patients. However, given their daunting complexity and often-knotty side effect profiles, these treatments also present difficult challenges to drug developers and regulators.

In a new series of reports, Clarivate analysts have taken a look at the path to market taken by our 2024 Drugs to Watch. In the case of Johnson & Johnson’s TALVEY® (talquetamab), a first-in-class bispecific antibody targeted to CD3 and GPRC5D for treatment of multiple myeloma, regulators were called on to balance serious side effects with profound unmet need.

J&J had earlier sought and received marketing authorization for a different bispecific antibody, TECVAYLI (teclistimab, one of our 2023 Drugs to Watch), through the United States Food and Drug Administration’s Accelerated Approval Program and the European Commission’s Conditional Marketing Authorization program. Both pathways were designed to facilitate earlier patient access to novel medications for serious conditions in which there is unmet medical need, based on surrogate endpoints or less comprehensive clinical data than normally required.

TECVAYLI and TALVEY target different receptors, but deliver a similar one-two punch by binding to both T-cells and cancer cells, rousing the immune system while inhibiting the diseased cells. Both sought initial approval for the treatment of heavily pre-treated relapsed/refractory multiple myeloma, an aggressive and drug-resistant form of the blood cancer for which prognoses are typically poor.

J&J was granted a Conditional Marketing Authorization (CMA) from the European Commission for TECVAYLI in August, 2022, followed by an FDA Accelerated Approval in February, 2024. TALVEY was given an Accelerated Approval in August, 2023, followed later that month by a Conditional Marketing Authorization from the European Commission. The availability of both drugs is sharply restricted in the U.S. under a joint Risk Evaluation and Mitigation Strategy due to severe potential side effects including neurotoxicity and hepatotoxicity, as well as cytokine storms, and CMAs must be renewed annually.

J&J’s RedirecTT-1 study is exploring the potential use of the drugs in combination for patients with relapsed for refractory multiple myeloma who were triple class exposed, including those with extramedullary disease, which spreads beyond the bone marrow.

Read our full report on the regulatory journey of TALVEY here. We have also taken a look at the regulatory strategies of ABRYSVO™ and AREXVY™, Casgevy™ and Lyfgenia™, TARPEYO®/Kinpeygo® and Zolbetuximab.

To learn more about how Clarivate helps innovative companies navigate a fast-changing global regulatory landscape, please visit us here.