.png)
CHMP Updates - March'25
- Oncofocus Team
- Jun 20
- 1 min read
Highlights from the CHMP March 2025 Meeting are out!
⭐ Indication Expansions:
💊 Pfizer's bosutinib (Bosulif; second-generation BCR-ABL TKI) use is extended to children aged 6 years and older with certain types of chronic myelogenous leukaemia, along with a new pharmaceutical form (hard capsules), associated with two new strengths (50 mg and 100 mg).
💊 AstraZeneca's acalabrutinib (Calquence; BTK inhibitor) + rituximab (anti-CD20 mAb) + bendamustine for the Tx of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).
💊 Bristol Myers Squibb's nivolumab (Opdivo; anti-PD-1) + platinum-based chemo as neoadjuvant treatment, followed by adjuvant nivolumab for the treatment of resectable, PD-L1≥1% NSCLC at high risk of recurrence.
👉 The CHMP also adopted a new pharmaceutical form (solution for injection), a new strength (600 mg), and a new route of administration (subcutaneous use of nivolumab).
💊 BeiGene's tislelizumab (Tevimbra; anti-PD-1) + etoposide + platinum chemo for the first-line treatment of adult patients with extensive-stage SCLC.
⭐ New Biosimilar
💊 Accord Healthcare's denosumab biosimilar (Jubereq; anti-RANKL) for the prevention of skeletal-related events in adults with advanced malignancies involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumour of bone.
Negative Recommendation on extension of therapeutic indication
💊 The CHMP recommended the refusal of extending the marketing authorization of Incyte pemigatinib (Pemazyre; FGFR inhibitor) to treat myeloid/lymphoid neoplasms with FGFR1 rearrangement.
Looking for more details on these recommendations, their registrational trial design and outcomes, and impact on the landscape? Reach out to us at support@oncofocus.com, and we will take it from there.
Comments