"Understanding the Potential Risks of Braftovi (encorafenib) and Zelboraf (vemurafenib) for Haemophagocytic lymphohistiocytosis"

The FAERS Potential Signals of Serious Risks/New Safety Information listed Braftovi (encorafenib) and Zelboraf (vemurafenib) with Haemophagocytic lymphohistiocytosisas a potential signal on their October - December 2023 listing.

Analyzing the FAERS data up to 2024 Q1 for reports submitted with these drugs as primary suspect drug, the PRR for Haemophagocytic lymphohistiocytosis is less than 2 when comparing the drugs within their ATC groups ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS, ANTINEOPLASTIC AGENTS, PROTEIN KINASE INHIBITORS, and B-RAF SERINE-THREONINE KINASE (BRAF) INHIBITORS, except for VEMURAFENIB in PROTEIN KINASE INHIBITORS.

ENCORAFENIB ATCs	PRR	MGPS	BCPNN	ROR	CHISQ
ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS	0.62494	0.62513	47.84651	0.62479	0.45024
ANTINEOPLASTIC AGENTS	0.48489	0.48515	45.63541	0.4845	1.09557
PROTEIN KINASE INHIBITORS	1.51464	1.51438	40.48709	1.51871	0.35137
B-RAF SERINE-THREONINE KINASE (BRAF) INHIBITORS	0.22895	0.22934	33.38995	0.2004	6.14804

VEMURAFENIB ATCs	PRR	MGPS	BCPNN	ROR	CHISQ
ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS	1.21658	1.21637	51.22601	1.21697	0.34718
ANTINEOPLASTIC AGENTS	0.94394	0.944	49.01491	0.94375	0.03004
PROTEIN KINASE INHIBITORS	2.94858	2.94666	43.86659	3.01987	11.7185
B-RAF SERINE-THREONINE KINASE (BRAF) INHIBITORS	0.44571	0.44625	36.76945	0.33957	9.68619

Haemophagocytic lymphohistiocytosis is included in Immune-mediated/autoimmune disorders (SMQ) under the narrow scope category. There are other adverse events reported for these drugs under the HLT Immune and associated conditions NEC. Haemophagocytic lymphohistiocytosis is included in the EMA IME list. Further analysis is required to confirm the potential signal.