(RTTNews) - AstraZeneca (AZN), a biopharmaceutical company, said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Enhertu for an additional early breast cancer setting and Alexion's Klygefa for adults with generalised myasthenia gravis (gMG).
The recommendations cover two different treatment areas and are now subject to European Commission decisions.
Enhertu (trastuzumab deruxtecan) is an antibody-drug conjugate developed and commercialized by AstraZeneca and Daiichi Sankyo. The drug is approved in the US and other countries for the same indication. Enhertu is currently approved in more than 75 countries for various breast cancer indications and in multiple markets for certain gastric and lung cancers.
The CHMP recommendation covers its use as a monotherapy for adults with resected HER2-positive early breast cancer who have residual invasive disease following neoadjuvant taxane-based and HER2-targeted treatment.
The recommendation is based on results from the Phase 3 DESTINY-Breast05 trial, which compared Enhertu with trastuzumab emtansine (T-DM1) in patients with HER2-positive breast cancer and residual invasive disease after neoadjuvant therapy. The trial's primary endpoint was invasive disease-free survival (IDFS).
According to the company, Enhertu reduced the risk of invasive disease recurrence or death by 53% compared with T-DM1. At three years, invasive disease-free survival was 92.4% with Enhertu versus 83.7% with T-DM1.
The safety profile of Enhertu was consistent with its known profile, with no new safety concerns identified.
Klygefa (gefurulimab), developed by Alexion, AstraZeneca Rare Disease, is a dual-binding C5 inhibitor being developed for adults with AChR antibody-positive gMG. It is designed for once-weekly subcutaneous self-administration and is recommended as an add-on to standard therapy. This therapy is already approved in Japan and other countries for certain adults with gMG.
Generalized myasthenia gravis is a chronic autoimmune neuromuscular disorder that causes fluctuating muscle weakness, often affecting the eye, facial, swallowing, speech and limb muscles.
The recommendation for Klygefa is based on the Phase 3 PREVAIL trial, which enrolled 260 adults with gMG. The trial met its primary endpoint, showing a statistically significant improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 26 compared with placebo.
The treatment difference was -1.6 points, with improvement observed as early as Week 1 and maintained through Week 26. The trial also met key secondary endpoints, according to AstraZeneca.
AstraZeneca said Klygefa was generally well tolerated, with a safety profile consistent with previous C5 inhibitors. If approved, the company said it would be the first and only dual-binding nanobody C5 inhibitor for AChR antibody-positive gMG in the EU.
AZN closed Friday's trade at $166.08, down 0.04%.
In the pre-market, shares are down 0.08% at $166.15.