EMA - Keytruda (pembrolizumab): approvazione estensioni di indicazioni

Sul sito EMA sono stati resi disponibili tutti i documenti aggiornati (EPAR, stampati e RMP) derivanti dalle EC decision di diverse procedure regolatorie volte alle estensione di indicazioni e al recepimento al 5.1 del RCP dei dati dello studio KEYNOTE-426.

1) Modifica dell'indicazione relativa al trattamento negli adulti del tumori alla cervice persistenti, recidivanti o metastatici basato sullo studio KEYNOTE-826:

da: “KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults”.

A:  “KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS ≥ 1”.

Extension of indication to include a new indication for Keytruda, in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent, or metastatic cervical cancer in adults; as a consequence, sections 4.1, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 35 of the RMP has also been submitted

2) Modifica dell'indicazione relativa al trattamento negli adulti di MSI H o dMMR basati sugli studi KEYNOTE-164 (KN164) e KEYNOTE-158 (KN158)

da: “KEYTRUDA as monotherapy is indicated for the treatment of unresectable or metastatic MSI-H or dMMR CRC, endometrial, gastric, small intestine, biliary, or pancreatic cancer in adults who have received prior therapy.”
a: “Keytruda as monotherapy is indicated for the treatment of the following MSI-H or dMMR tumours in adults with:
- unresectable or metastatic colorectal cancer after previous fluoropyrimidine-based combination therapy;
- advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation;
- unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.”