EU Okays Afatinib for NSCLC, Filgrastim and Defibrotide.

The European Committee for Medicinal Products for Human Use (CHMP) has recommended that the targeted agent afatinib (Giotrif, Boehringer Ingelheim) be approved for use in nonsmall-cell lung cancer (NSCLC) that tests positive for EGFRmutations.

Afatinib was recently approved for this indication in the United States under the trade name Gilotrif.

This is the third drug to target EGFR mutations in NSCLC; it joins erlotinib (Tarceva) and gefitinib (Iressa). Both are available in most countries in the world, with one notable exception — gefitinib is not available in the United States.

About 10% to 15% of NSCLC is positive for EGFR mutations in Western populations; in Asian populations, the incidence is higher.

Filgrastim Biosimilar

The CHMP also recommended approval for the growth factor filgrastim (Grastofil, Apotex) for the treatment of neutropenia, which is a biosimilar to Neupogen (Amgen). “Studies have shown Grastofil to have a comparable quality, safety, and efficacy profile to Neupogen,” the committee noted.

Filgrastim is a granulocyte colony-stimulating factor that regulates the production and release of functional neutrophils from the bone marrow. It is used in cancer patients to counteract the myelosuppressive effects of chemotherapy by reducing the duration of neutropenia and the incidence of febrile neutropenia.

Change of Mind on Defibrotide

In addition, in its July meeting, the CHMP recommended the approval of defibrotide (Defitelio, Gentium) for use in the treatment of severe hepatic veno-occlusive disease, also known as sinusoidal obstructive syndrome, related to hematopoietic stem cell transplantation. The product has orphan drug status for this indication.

The CHMP issued a negative opinion on this product in March 2012. But at the request of the company, the committee re-examined its stance. After that re-examination, it issued a positive opinion for the very narrow indication of severe veno-occlusive disease.

The mechanism of action of defibrotide has not been fully elucidated, the committee notes in its summary. The drug increases the breakdown of blood clots, and it might also protect cells lining the blood vessels, it notes. The most common adverse events are hemorrhage, hypotension, and coagulopathy.


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