EMA Gives Positive Opinion on Two of Janssen’s Bispecific Antibodies

The Janssen Pharmaceutical Companies of Johnson & Johnson announced on July 21, 2023 that they have received a positive opinion for two novel bispecific antibodies from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The CHMP has recommended conditional marketing authorization for TALVEY (talquetamab) and has recommended the approval of a Type II variation for teclistamab (marketed under the brand name TECVAYLI).

Janssen is seeking approval of talquetamab as a monotherapy to treat adult patients with relapsed and refractory multiple myeloma (RRMM). The indication is for RRMM patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, but who have still demonstrated disease progression on the last therapy. Talquetamab, a subcutaneous bispecific antibody, binds G protein-coupled receptor class C group 5 member D (GPRC5D), a novel target on multiple myeloma cells, and CD3, on T-cells, according to a company press release.

The CHMP’s recommendation for the Type II variation for teclistamab means that, if approved, then the dosing schedule for the therapy can be reduced to a biweekly dosing schedule in patients who have achieved a complete response or better for six months or longer. Teclistamab is a bispecific antibody that targets B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T-cells. According to the company press release, it is the first bispecific antibody with this mechanism of action to be licensed in Europe for treating adult RRMM patients who have had at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and who have demonstrated disease progression on the last therapy.

“With talquetamab, a novel bispecific antibody targeting GPRC5D, we look to … bring forward a vital new treatment option for patients with relapsed and refractory multiple myeloma, who have a poor prognosis,” said Edmond Chan, senior director EMEA Therapeutic Area Lead Hematology, Janssen-Cilag, in the press release. “Today’s recommendation from the CHMP marks an exciting step for patients who continue to face the challenges of this difficult-to-treat blood cancer. We look forward to working with health authorities to bring talquetamab to patients in need across the region as soon as possible, while we continue our focus on enhancing a robust multiple myeloma portfolio of therapeutics and regimens.”

“Pending approval, this variation for teclistamab will be an important step forward for this first BCMA bispecific therapy, offering flexible, less frequent dosing depending on a patient’s response,” said Sen Zhuang, vice president, Clinical Research and Development, Janssen Research & Development, in the release.

Source: Johnson & Johnson