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CHMP Meeting highlights April 2022 (news for follicular lymphoma and oncology treatments)

  • 22 aprile 2022
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EMA’s human medicines committee (CHMP) recommended four medicines for approval in the European Union (EU) and extensions of therapeutic indication for seven medicines, at its April 2022 meeting, including the following of interest:

- Roche's drug Lunsumio (mosunetuzumab) received a positive opinion from the CHMP for a conditional marketing authorisation, as monotherapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

- Novartis's drug Tabrecta (capmatinib) received a positive opinion from the CHMP for a marketing authorisation in EU, as monotherapy, for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

- MSD's drug Keytruda (pembrolizumab) received a positive opinion from the CHMP for extension indication in Triple‑negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, for the treatment of adults with locally advanced, or early‑stage triple‑negative breast cancer at high risk of recurrence.

- Eli Lilly's drug Retsevmo (selpercatinib) received a positive opinion from the CHMP for extension indication, as monotherapy, for the treatment of adults with advanced RET fusion positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

- Roche's drug Tecentriq (atezolizumab) received a positive opinion from the CHMP for a new indication for the treatment of Early-stage non-small cell lung cancer (NSCLC), as monotherapy as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and who do not have EGFR mutant or ALK‑positive NSCLC.

- Gilead's drug Yescarta (axicabtagene ciloleucel) received a postive opinion from the CHMP for a new indication for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.

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