July/August 2025 • PharmaTimes Magazine • 6
// TREATMENTS //
A new investigational treatment has shown strong and lasting responses in multiple myeloma patients with extramedullary disease (EMD), a particularly aggressive and difficult-to-treat form of the cancer.
Results from the phase 2 RedirecTT-1 study indicate a 78.9 percent overall response rate (ORR) with the combination of TALVEY (talquetamab) and TECVAYLI (teclistamab). These dual bispecific antibodies target both GPRC5D and BCMA, potentially improving response rates in heavily pretreated patients.
EMD occurs when myeloma cells form tumours outside the bones, often leading to poorer outcomes and limited treatment options. On average, patients with triple-class exposed (TCE) relapsed/refractory multiple myeloma and EMD have an ORR below 40 percent and median progression-free survival of less than six months.
Yael Cohen, head of the myeloma unit at Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel, said: “The investigational combination of talquetamab and teclistamab has demonstrated deep, durable responses in patients with relapsed or refractory multiple myeloma, and now shows great promise in those with extramedullary myeloma, where standard therapies often fall short.”
The study enrolled 90 patients, with 84.4 percent being triple-class refractory. Among responders, 66.2 percent remained in response at the data cutoff, with a median follow-up of 13.4 months.
The combination therapy also showed a consistent safety profile, with low discontinuation rates due to adverse events. Patients had the option to switch to monthly dosing, which may improve tolerability.
The findings were presented at the 2025 European Hematology Association Congress. Researchers hope the results will lead to new treatment options for patients facing aggressive forms of multiple myeloma.
Santen has announced that the European Commission has granted market authorisation for Ryjunea, a low-dose atropine eye drop (0.1 mg/ml), to slow the progression of paediatric myopia.
This approval represents a milestone in childhood eye care and offers a new option for managing myopia in children.
Ryjunea is indicated for children aged three to 14 years at treatment initiation, with myopia progression of 0.5 d or more per year and severity between -0.5 d and -6.0 d.
The product is licensed from Sydnexis Inc. to Santen’s affiliate, Santen SA, for registration and commercialisation across Europe, the Middle East and Africa.
The approval follows a positive opinion from the committee for medicinal products for human use and is backed by the phase 3 star study.
The study showed that Ryjunea reduced the annual progression of myopia by 30% over two years compared to placebo, with a favourable safety and tolerability profile.
Myopia, or short-sightedness, often develops in early childhood. If left unmanaged, it increases the risk of severe eye conditions later in life.
In Europe, approximately one in three children and adolescents are projected to be affected by 2050. Until now, there was no approved pharmacological treatment in the EU to slow progression.
Peter Sallstig, Chief Medical Officer at Santen, said: “With this approval, clinicians now have an evidence-based option to help slow the progression of myopia.”