The U.S. FDA have granted priority reviews for Roche’s cancer drug polatuzumab vedotin, as well as personalised medication entrectinib.
The priority review for polatuzumab veodtin comes on the back of results from the phase Ib/II GO29365 study involving 80 patients.
Polatuzumab vedotin is a potential first-in-class antibody drug conjugate which in combination with Rituxan (rituximab) and bendamustine, for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma has shown to improve clinical outcomes with median progression free survival (PFS) increasing to 7.6 months versus just 2 months for those on Rituxan alone. Additionally the combination drugs also led to a 66% reduction in the risk of disease worsening or death.
The second drug to be granted priority review was entrectinib, which is a selective tyrosine kinase inhibitor being developed for non-small cell lung cancer (NSCLC) patients whose tumours carry NTRK or ROS1 fusions.
Sandra Horning, MD, chief medical officer and head of global product development, said: “Entrectinib represents a unique approach to cancer treatment that can potentially target a range of hard-to-treat and rare NTRK fusion-positive tumours regardless of their site of origin as well as treat ROS1-positive non-small cell lung cancer.
“By combining comprehensive genomic profiling with actionable targeted therapies, like entrectinib, we are advancing our personalised healthcare goal to find the right treatment for each patient.
“We are working closely with the FDA to make this potential new option available as soon as possible.”
Entrectinib was acquired by Roche when it bought biotech firm Ignyta for $1.7bn in 2017 when it was also granted FDA Breakthrough Designation and priority medicines (PRIME) by the European Medicines Agency, as well as Sakigake designation by Japanese health authorities.