As expected, European regulators have issued a green light for GlaxoSmithKline 's first-in-class Mekinist (trametinib) as a treatment for unresectable or metastatic melanoma with a BRAF V600 mutation.
The drug, part of a trio being sold to Novartis for up to $16 billion, is the first cancer treatment that selectively targets the MEK protein kinase, which regulates the normal growth and death of cells and plays a role in metastatic melanoma development.
Approval by the European Commission is based on findings from the randomised, open-label Phase III METRIC study involving 322 patients with BRAF-mutant melanoma who were treatment-naïve or may have received one prior chemotherapy treatment in the metastatic setting.
This showed that treatment with Mekinist resulted in a statistically significant increase in progression-free survival (PFS) compared to chemotherapy, with a median PFS of 4.8 months versus 1.5 months.
New use for Arzerra
The regulator also issued a new green light for Arzerra (ofatumumab), clearing its first-line use in combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy.
Clinical data show that treatment with Arzerra and chlorambucil demonstrated a statistically significant, 71% improvement in median progression-free survival (PFS) compared to chlorambucil alone (22.4 months versus 13.1 months, respectively), while combining Arzerra with bendamustine gave an overall response rate of 95%.
Paolo Paoletti, President of Oncology, GSK, said the approval means "a new treatment option for appropriate CLL patients and enables physicians flexibility in their choice of adjunct chemotherapy - chlorambucil or bendamustine".
The drug, developed with Genmab, is also authorised in the EU for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.
Japan OK's COPD drug
Elsewhere, regulators in Japan gave the nod to GSK's Anoro Ellipta (umeclidinium/vilanterol) for the relief of various symptoms due to airway obstruction with chronic obstructive pulmonary diseases (chronic bronchitis, pulmonary emphysema).
The move sparks a $10-million-milestone agreement to GSK from partner Theravance, as per the terms of their LABA deal signed back in 2002.