Prodotti competitors / Area Onco-Ema, Area Kite
Meeting highlights from CHMP 12-15 September 2022 - Oncology
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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