CHMP recommends Darzalex (daratumumab) as a treatment for relapsed and refractory multiple myeloma. Janssen Cilag
Janssen-Cilag International NV announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending a conditional marketing authorisation for first-in-class CD38 immunotherapy Darzalex (daratumumab) in the European Union. The recommended indication is for monotherapy of adult patients with relapsed and refractory multiple myeloma (MM), whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
This application was reviewed under an accelerated assessment by the CHMP, a process reserved for medicinal products expected to be of major public health interest, particularly from the point of view of therapeutic innovation.
The Opinion of the CHMP was based on a review of data from the Phase II MMY2002 (SIRIUS) study, published in The Lancet, the Phase 1/II GEN501 study, published in The New England Journal of Medicine, and data from three additional supportive studies. These studies included heavily pre-treated patients with relapsed and refractory multiple myeloma who had exhausted other approved treatment options and whose disease was progressive at enrolment. Findings from a combined efficacy analysis of the GEN501 and MMY2002 (SIRIUS) trials demonstrated that after a mean follow-up of 14.8 months, the estimated median OS for single-agent daratumumab (16 mg/kg) in these heavily pre-treated patients was 20 months (95 percent CI, 15-not estimable). The overall response rate (ORR) for the combined analysis was 31 percent, and 83 percent of patients achieved stable disease or better.
Related news and insights
AbbVie has announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of risankizumab (Skyrizi 150 mg, subcutaneous injection at week 0, week 4 and every 12 weeks thereafter) alone or in combination with methotrexate (MTX), for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
Merck Inc., announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. The CHMP recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected by the end of the year.
Merck Inc., and Eisai announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted positive opinions recommending approval of the combination of Keytruda, Merck’s anti-PD-1 therapy, plus Lenvima (marketed as Kisplyx in the European Union [EU]) for the treatment of advanced renal cell carcinoma [RCC]), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for two different indications.