EU OK for Generic Carmustine for Brain Tumors and Lymphoma

EU OK for Generic Carmustine for Brain Tumors and Lymphoma

At its latest meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of a generic version of carmustine (Carmustine Obvius, from Obvius Investment BV) for use in the treatment of brain tumors, non-Hodgkin’s lymphoma, and Hodgkin’s disease.

This is a generic version of Carmubris, a proprietary product that has been available in Europe since 1996. Because the drug is administered intravenously and is 100% bioavailable, a bioequivalence study comparing Carmustine Obvius with the reference product Carmubris was not required, the committee noted.

The full indication is for use of carmustine 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.”

Indication Extensions

The CHMP recommended approval of indication extensions for the following cancer drugs:

• Dasitinib (Sprycel, Bristol-Myers Squibb), for use in pediatric patients. The additional indication will be for use in pediatric patients with newly diagnosed Philadelphia chromosome–positive chronic myelogenous leukemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP in cases in which there was resistance to or intolerance of prior therapy, including imatinib (Gleevec, Novartis). The product also has a new formulation — it is now available as a powder for oral suspension, for use in pediatric patients.

• Osimertinib (Tagrisso, AstraZeneca) for first-line treatment of adult patients with locally advanced or metastatic non–small cell lung cancer with activating epidermal growth factor receptor mutations.

• Ipilimumab (Yervoy, Bristol-Myers Squibb) will have a new indication for use in combination with nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of advanced melanoma.

In addition, the CHMP decided to remove an indication from the product labeling for pertuzumab (Perjeta, Roche), an HER2-targeted agent used in breast cancer. The indication that has been removed is for its neoadjuvant use in combination with trastuzumab and chemotherapy for HER2-positive breast cancer in which there is high risk for recurrence.

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