At its most recent meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) made a host of recommendations about a range of oncology-related agents, both endorsing and dismissing products.
The CHMP adopted a positive opinion of — and recommended granting market authorization to — the biosimilar bevacizumab (Mvasi, Amgen), for treatment of a variety of cancers, including colorectal, breast, non-small cell lung, renal cell, epithelial ovarian, fallopian tube or primary peritoneal, and cervical. It is equivalent to the reference product, Avastin (Roche).
The recommendation comes just weeks after the US Food and Drug Administration (FDA) approved Mvasi, making it the first biosimilar approved for oncology use in the United States.
However, the European Union is ahead of the United States in terms of approving other anticancer biosimilars, such as the like-products of rituximab and trastuzumab.
The term “biosimilar” means that the agent has the same efficacy and adverse effect profile as the reference product. The main difference is price, with biosimilars expected to be cheaper.
The CHMP also adopted a positive opinion of extending the indication of brentuximab vedotin (Adcetris, Takeda) to include the treatment of CD30+ cutaneous T-cell lymphoma after prior systemic therapy.
The new indication recommendation comes just 1 day after the FDA fully approved brentuximab for the same patients.
In the European Union, the drug is also approved for use in relapsed or refractory CD30+ Hodgkin lymphoma after autologous stem cell transplant (ASCT) or after at least two prior therapies when ASCT or multiagent chemotherapy is not an option. It is also for use in the treatment of adults with CD30+ Hodgkin lymphoma at increased risk for relapse or progression after ASCT and for adults with relapsed or refractory systemic anaplastic large cell lymphoma.
The CHMP recommended granting a marketing authorization for the antiviral letermovir (Prevymis, Merck) to help prevent cytomegalovirus (CMV) infections and disease in adults previously exposed to this common virus who have received an allogeneic hematopoietic stem cell transplant.
Earlier this month, the FDA approved letermovir for the same use. The agency said that letermovir is the first drug okayed for this indication. It belongs to a new class of non-nucleoside CMV inhibitors that prevent the virus from replicating.
The generic Fulvestrant Mylan (fulvestrant), for the treatment of locally advanced or metastatic breast cancer, was also recommended for approval by the CHMP.
On the downside, the CHMP had a negative opinion of etirinotecan (Onzeald, Nektar Therapeutics) for the treatment of metastatic breast cancer that has spread to the brain. This rejection was a re-examination of the product, as it was previously not recommended by the committee.
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