Pharmaceutical Market Europe • February 2026 • 6
NEWS
Biogen’s litifilimab receives FDA Breakthrough Therapy Designation for lupus
Biogen’s litifilimab has received Breakthrough Therapy Designation from the US FDA to treat cutaneous lupus erythematosus (CLE).
CLE is a chronic autoimmune skin disorder characterised by symptoms such as rash, pain, itch and photosensitivity. CLE patients also often experience skin damage that leads to scarring, alopecia and dyspigmentation, significantly affecting quality of life.
Around 90% of lupus patients are women, and symptoms typically begin from aged 15 to 40. Lupus has a disproportionately high impact on certain ethno-racial groups, such as African American, Asian and Hispanic/Latino communities.
There is currently no cure for lupus. Standard-of-care therapies for CLE include topical steroids, antimalarials and immunosuppressants, but these treatments manage symptoms rather than slowing or preventing disease progression.
Victoria Werth, professor of dermatology at the Perelman School of Medicine, University of Pennsylvania, said: “With topical steroids and antimalarials as the initial therapies for managing CLE and no alternatives specifically approved for CLE, there is a need for effective, targeted treatments, and that could be a drug like litifilimab.”
Johnson & Johnson’s Darzalex Faspro regimen receives FDA approval for multiple myeloma
Johnson & Johnson has announced that its Darzalex Faspro-based regimen (daratumumab and hyaluronidase, in combination with bortezomib, lenalidomide and dexamethasone (D-VRd)), has received approval from the US FDA to treat adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
The approval is based on results from the phase 3 CEPHEUS study, which compared the safety and efficacy of the D-VRd regimen with bortezomib, lenalidomide and dexamethasone (VRd) alone.
Almost five years later, the Darzalex Faspro-based regimen showed significantly increased rates of complete response or better at 81.2% vs 61.6% with VRd. The study showed that the safety profile of the Darzalex Faspro-based regimen was favourable, with the most common adverse events including upper respiratory tract infection, sensory neuropathy and musculoskeletal pain.
Multiple myeloma is a blood cancer affecting plasma cells. It is the second most common blood cancer globally. Estimates suggest that over 36,000 people will be diagnosed with multiple myeloma in the US, with over 12,000 deaths in 2026. Multiple myeloma has an average five-year survival rate of 59.8% and is currently incurable.
FDA Priority Review given to Datroway for breast cancer treatment
The US FDA has given Priority Review to a supplemental Biologics License Application (sBLA) for Datroway (datopotamab deruxtecan) to treat adults with unresectable or metastatic triple-negative breast cancer (TNBC).
AstraZeneca and Daiichi Sankyo’s antibody drug conjugate is suitable for adults who are not candidates for PD-1/PD-L1 inhibitor therapy.
Priority Review is granted by the FDA to therapies that have the potential to improve on available treatments, either through enhanced safety or efficacy, prevention of serious conditions or improved patient compliance. The sBLA for Datroway is being reviewed under Project Orbis, which helps to accelerate the approval of oncology treatments.
Around 70% of metastatic TNBC patients are not eligible for immunotherapy. In these cases, the only approved first-line treatment is chemotherapy. There is a significant unmet medical need for treatments to fill this gap.
The sBLA for Datroway follows the release of data from the phase 3 TROPION-Breast02 trial. Compared to first-line chemotherapy, Datroway showed a five-month improvement in median overall survival and a 43% reduction in risk of progression or death in immunotherapy-ineligible metastatic TNBC patients. Datroway also showed greater durability of treatment response.
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