NEW BRUNSWICK (dpa-AFX) - The European Commission delivered notable regulatory decisions this week - expanding the indication for Johnson & Johnson's prostate cancer therapy, approving a new dosing regimen for Protalix BioTherapeutics' enzyme replacement therapy Elfabrio, and granting a second indication to Incyte's immuno-oncology drug Zynyz.
Johnson & Johnson (JNJ)
On March 9, 2026, the European Commission approved Johnson & Johnson's AKEEGA with prednisone or prednisolone in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA1/2 mutations. This marks the second approval for AKEEGA in the European Union.
The approval was based on the results of a phase 3 trial, dubbed AMPLITUDE, in which the AKEEGA regimen demonstrated a clinically meaningful delay in disease progression, nearly halving the risk of progression or death, with an early trend toward improved overall survival versus standard of care, say androgen deprivation therapy (ADT) combined with either chemotherapy or an androgen receptor-targeted agent.
AKEEGA, given with prednisone or prednisolone, received its initial EC approval in April 2023 for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations.
The drug is also approved in the U.S. for BRCA2-mutated metastatic castration-sensitive prostate cancer and BRCA-mutated metastatic castration-resistant prostate cancer.
The company does not disclose product-level sales for AKEEGA in its quarterly or annual reports.
Protalix BioTherapeutics Inc. (PLX)
Protalix BioTherapeutics received European Commission approval for the additional dosing regimen of 2mg/kg every four weeks for Elfabrio in adults living with Fabry disease who are stable with an enzyme replacement therapy (ERT).
Fabry disease is a rare genetic disorder in which the body does not produce enough of the enzyme alpha-galactosidase A, which normally breaks down a fatty substance known as globotriaosylceramide (Gb3). When this enzyme is deficient, Gb3 accumulates in various organs, including the kidneys and heart, potentially leading to complications such as kidney failure and heart disease.
Elfabrio was approved by the European Commission in May 2023, with an original dosing regimen of 1 mg/kg every two weeks. It is developed by Protalix BioTherapeutics in collaboration with Chiesi Global Rare Diseases.
Commenting on the expanded approval, Giacomo Chiesi, Executive Vice President, Chiesi Global Rare Diseases, said, 'Because Fabry disease requires lifelong treatment, the cadence of therapy inevitably becomes part of everyday life for patients and caregivers. By introducing an option that extends the infusion interval from every two weeks to every four weeks for eligible patients on stable ERT, we are offering families greater flexibility and the possibility to ease the overall burden of treatment.
In the U.S., Elfabrio is approved in the dose of 1 mg/kg every 2 weeks, administered as an intravenous infusion.
In the third quarter of 2025, Protalix recorded $8.8 million in sales of Elfabrio to Chiesi compared to $6.8 million in Q3, 2024.
Incyte (INCY)
Incyte's immuno-oncology drug Zynyz received approval for a second indication in Europe on March 6, 2026, allowing its use for the first-line treatment of advanced squamous cell carcinoma of the anal canal.
Specifically, the drug is approved in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC), a rare cancer for which meaningful treatment advances have not occurred in several decades.
Zynyz was previously approved by the European Commission in April 2024 as a monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.
The drug is also approved in the U.S. for the treatment of advanced anal cancer and Merkel cell carcinoma.
The net product revenue of Zynyz was $66 million in the full year of 2025, compared to $3.19 million in 2024.
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