The US FDA has issued a filing acceptance under priority review for a New Drug Application for Roche’s fenebrutinib as a treatment for patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

Fenebrutinib became the first investigational medicine in more than a decade to slow disability progression in a phase 3 PPMS trial, with numerical benefit vs Ocrevus. Fenebrutinib cut relapses by 51% and 58% vs teriflunomide in phase 3 RMS trials while showing a consistent, positive trend in delaying disability.

Fenebrutinib is designed to address two drivers of MS – acute inflammation causing relapses and chronic brain inflammation driving disability progression. If approved, fenebrutinib would become the first BTK inhibitor and first high-efficacy oral treatment for both RMS and PPMS, offering a new option for the nearly one million Americans living with MS.

MS is a chronic disease that affects more than three million people worldwide. People with all forms of MS experience disease progression from the beginning of their disease. Therefore, an important goal of treating MS is to slow, stop and ideally prevent progression as early as possible.

Concurrently addressing the life-disrupting relapses and long-term disease progression – the slow, steady loss of physical and mental abilities over time – remains one of the greatest challenges in MS. Fenebrutinib is designed to act throughout the body and to cross the blood-brain barrier into the central nervous system to target both the acute inflammation that causes relapses and the chronic inflammation that is thought to drive disability progression.

Approximately 85% of people with MS are initially diagnosed with relapsing-remitting multiple sclerosis (RRMS). Relapsing forms of the disease (RMS) include RRMS and active secondary progressive MS, and people with RMS experience relapses and worsening disability over time. Primary progressive multiple sclerosis (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission.

Approximately 15% of people with multiple sclerosis are diagnosed with the primary progressive form of the disease. Until the FDA approval of Ocrevus, there had been no FDA-approved treatments for PPMS, and Ocrevus is still the only approved treatment for PPMS.

AstraZeneca has announced results from the ADAURA phase 3 trial showing Tagrisso (osimertinib) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at eight years compared to placebo. This OS benefit was seen in patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection.

Lung cancer is the leading cause of cancer death globally, accounting for almost one in five (19%) cancer deaths. Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% of patients diagnosed with NSCLC.

At eight years of follow-up, results showed that Tagrisso continued to show an OS benefit, reducing the risk of death compared to placebo by 47% in the primary population. In the overall trial population, Tagrisso reduced the risk of death compared to placebo by 48%.

An estimated 74% of patients treated with Tagrisso were alive at eight years versus 58% of those treated with placebo in the primary population. In the overall trial population, an estimated 79% of patients treated with Tagrisso were alive at eight years versus 64% of those treated with placebo.