The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the generic medication Carmustine Obvius (carmustine) for the treatment of non-Hodgkin’s lymphoma, Hodgkin’s lymphoma, and brain tumors.
The CHMP is EMA’s committee responsible for human medicines. Its recommendation now will be reviewed by the European Commission, which has the authority to approve new medicines.
The medication, a product from Dutch company Obvius Investment B.V., is a generic of Carmubris, which has been available in Europe since July 1996. The active ingredient of Carmustine Obvius, carmustine, prevents DNA replication (making a copy of a DNA strand during cell division) and transcription (the first step of gene expression), in which DNA in converted into messenger RNA. Both of these molecular processes are key events in cancer development.
If approved, Carmustine Obvius will be available as a 100 mg powder for solution for intravenous infusion. Due to this intravenous route and being 100 percent bioavailable, which means that all the product reaches systemic circulation after administration, CHMP did not require a bioequivalence study comparing the generic with Carmubris. The agency proposes prescription of Carmustine Obvius by experienced physicians in the treatment of cancer patients.
Carmustine’s full indication is for use in the “treatment of new or recurrent brain tumors — glioblastoma, medulloblastoma, astrocytoma, and metastatic brain tumors; and second-line treatment of non-Hodgkin’s lymphomas and Hodgkin’s disease,” according to the EMA’s summary of opinion. The EMA’s Q&A for generic medications can be found here.
Besides the approval of Carmustine Obvius, the CHMP recommended approval of indication extensions for other cancer therapies, including:
- Sprycel (dasatinib) for use in pediatric patients with newly diagnosed Philadelphia chromosome–positive chronic myelogenous leukemia in chronic phase, or in cases with resistance to or intolerance of prior treatment, including Gleevec (imatinib mesylate). The medication also is available as a powder for oral suspension;
- Tagrisso (osimertinib) for first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer with activating epidermal growth factor receptor mutations;
- Yervoy (ipilimumab) for the treatment of patients with advanced melanoma in combination with Opdivo (nivolumab).