Amgen said the European Commission has granted a conditional marketing authorization to market its colorectal cancer treatment drug Vectibix.
EU approved Vectibix (panitumumab) as monotherapy for the treatment of patients with epidermal growth factor receptor (EGFr) expressing metastatic colorectal cancer (mCRC) with non-mutated (wild-type) KRAS genes after failure of standard chemotherapy regimens.
Vectibix, a fully human anti-EGFr monoclonal antibody, has been granted a positive Commission decision in the European Union (EU) based upon a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for marketing authorization in September of this year. This approval is based on a positive benefit / risk assessment in a patient population that currently has few treatment options available to them. As part of the CHMP review, clinical data supporting the utility of KRAS mutation status as a biomarker for clinical outcome were provided.
"It is an exciting time in the oncology arena as we see a shift towards individualized patient care," said Willard Dere, M.D., senior vice president and international chief medical officer, Amgen. "We are pleased that Vectibix has received conditional marketing authorization allowing metastatic colorectal cancer patients to have access to a new targeted treatment option.
"These biomarker data were generated from a prospectively defined analysis of the phase III, randomised, controlled clinical trial "408" that investigated the treatment effect of KRAS status (non-mutated versus mutated) in Vectibix patients with mCRC. The analysis demonstrated that the effect of Vectibix on progression-free survival (PFS) was confined exclusively to the approximately 60 percent of patients whose tumours harbour normal, non-mutated (wild-type) KRAS. Vectibix had no clinical benefit in patients who had tumours with mutations in KRAS regardless of the endpoint studied. Previously reported pivotal results from "408" demonstrated that Vectibix monotherapy significantly improved PFS and response rates in heavily pre-treated patients with mCRC after failure of standard chemotherapy versus best supportive care.
KRAS plays an important role in cell growth regulation and oncogenesis. Anti-EGFr therapies work by blocking the activation of EGFr, thereby inhibiting downstream events that lead to malignant signalling. However, in patients with tumours harbouring a mutated or activated KRAS, the KRAS protein is always turned "on" regardless of whether EGFr has been activated or therapeutically inhibited. Thus, in patients with mutated KRAS, signalling continues despite anti-EGFr therapy. Mutant KRAS is detected in approximately 40 percent of CRC tumours.
"Being able to select which patients are more likely to respond to therapy is an important step forward in the treatment of metastatic colorectal cancer," said Professor Eric Van Cutsem, Digestive Oncology Unit, University Hospital, Leuven, Belgium, a Vectibix investigator. "The ability to predict the patient population more likely to respond to Vectibix could potentially reduce drug exposure in patients who we know will not respond."
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