CHMP reverses earlier decision and recommends approval of Nerlynx in breast cancer.- Puma Biotech.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorisation for the medicinal product Nerlynx (neratinib), from Puma Biotechnology, for the treatment of patients with a type of breast cancer called early-stage hormone-receptor positive, HER2-positive breast cancer. On 22 February 2018, the CHMP had originally adopted a negative opinion for Nerlynx for broader use in HER2-positive early breast cancer. At the request of the applicant, the CHMP started a re-examination of its opinion.

Following the re-examination, the CHMP adopted a final positive opinion on 28 June 2018, but in a restricted patient population. Nerlynx is expected to be used to treat adults with early breast cancer who have undergone surgery, to reduce the risk of their cancer coming back. Nerlynx is expected to be given for one year, following treatment with another medicine, trastuzumab, for the same purpose. It is intended for use only in breast cancers that produce high levels of a protein called HER2, which helps cells to divide and grow (HER2-positive breast cancer),and that also have receptors (targets) for the female sex hormones(hormone-receptor positive breast cancer).

The full indication is: "Nerlynx is indicated for the extended adjuvant treatment of adult patients with early -stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy".