EMA Validation Puts Neratinib One Step Closer to Approval for HER2+ Breast Cancer

Excerpt:

“The developer of neratinib, Puma Biotechnology, has announced the European Medicines Agency (EMA) has validated the marketing authorization application for neratinib as a potential extended adjuvant therapy for patients with HER2-positive early stage breast cancer following 12 months of trastuzumab (Herceptin).

“The validation confirms the completion of the submission process and starts the formal review by the Committee for Medicinal Products for Human Use (CHMP) and the subsequent final approval decision by the European Commission.

“The application was based on findings from the phase III ExteNET study, which were published in the Lancet Oncology. In this study, extended treatment with neratinib demonstrated a 2-year disease-free survival (DFS) rate of 93.9% compared with 91.6% in the placebo arm, representing a 33% improvement versus placebo (HR, 0.67; P = .009).”

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Amgen Submits Marketing Authorization Application for Oncolytic Immunotherapy in EU

Editor’s note: Before a drug can be made widely available to patients in the European Union, it must first be approved by the European Medicines Agency. The drug company Amgen recently submitted a proposal for approval of its melanoma treatment talimogene laherparepvec (T-VEC). T-VEC is a modified virus that is injected directly into tumors, where it destroys tumor cells. It has shown some promising results in clinical trials—research studies in volunteer patients.

“Amgen announced the submission of a marketing authorization application to the European Medicines Agency for talimogene laherparepvec for the treatment of regionally or distantly metastatic melanoma in adults.

“If the application is approved, talimogene laherparepvec will represent the first in a class of novel agents known as oncolytic immunotherapies, according to a company press release.

“The marketing authorization application contains data from more than 400 patients and is based on a global, randomized, open-label, phase 3 trial evaluating its efficacy and safety in patients with stage IIIB, IIIC or IV melanoma when resection was not recommended.”


UPDATE 1-EU Agency Backs Approval of New GlaxoSmithKline Melanoma Drug

“GlaxoSmithKline’s melanoma drug Mekinist – one of several drugs being sold to Novartis under an asset swap deal – has been recommended for approval by European regulators.

“The European Medicines Agency (EMA) said on Friday its experts had backed the drug, also known as trametinib, as a treatment for unresectable or metastatic melanoma in patients with a mutation of a gene known as BRAF.”