Meeting highlights from CHMP 12-15 September 2022 - Oncology

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Source: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-september-2022

On the 16th of September 2022, CHMP released its meeting highlights for the month of September. The main discussion points of the meeting are as follows:

Medicines Recommended for Approval

Zynlonta (loncastuximab tesirine) - ADC Therapeutics (NL) B.V.

  • Indications: Intended for the treatment of adult patients with diffuse large B-cell Lymphoma and high-grade B-cell lymphoma
  • Positive CHMP recommendation for the new medicine

Sorafenib Accord (sorafenib) - Accord Healthcare S.L.U.

  • Indications: The treatment of hepatocellular carcinoma and renal cell carcinoma.
  • Positive CHMP recommendation for the new generic medicine.

Recommendations on extensions of therapeutic indication

Xalkori (crizotinib) - Pfizer Europe MA EEIG

  • Extension of Indication: include treatment of paediatric patients (age ≥ 6 to < 18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) and with unresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumour (IMT).
  • Positive CHMP recommendation on extension of indcations

Withdrawals of initial applications

Exkivity (mobocertinib) - Takeda Pharma A/S

  • Withdrawal of Marketing Authorisation Application: product as intended for use in adults with advanced non-small lung cancer (NSCLC) with ‘EGFR exon 20 insertion mutations.
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