Nivolumab BMS

Withdrawn

Human

Details

EMA number	EMEA/H/C/003840
ATC code	L01XC17
Authorisation	20 July 2015
Withdrawn	30 November 2015
Revision	-

EMA page

Therapeutic indication

Nivolumab BMS is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.

MeSH: Carcinoma, Non-Small-Cell Lung

Group: Antineoplastic and immunomodulating agents;Monoclonal antibodies

Active substances

nivolumab

Marketing Authorisation Holder

Bristol-Myers Squibb Pharma EEIG

MAH

🇺🇸 Also approved in the US (FDA)

OPDUALAG — BRISTOL MYERS SQUIBB, approved 2026-06-08 (BLA761234).

Most reported adverse events (US / FAERS)

64,617 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

death

11,788

malignant neoplasm progression

9,758

off label use

6,190

diarrhoea

5,166

Timeline

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Nivolumab BMS withdrawn

30 Nov 2015

withdrawnregulatory

Nivolumab BMS authorised

20 Jul 2015

authorisedregulatory

🇺🇸 Also approved in the US (FDA)

OPDUALAG — BRISTOL MYERS SQUIBB, approved 2026-06-08 (BLA761234).

Most reported adverse events (US / FAERS)

64,617 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

death

11,788

malignant neoplasm progression

9,758

off label use

6,190

diarrhoea

5,166

fatigue

4,127

pyrexia

3,661

intentional product use issue

3,331

nausea

3,137

rash

3,047

decreased appetite

2,872

dyspnoea

2,654

pneumonia

2,423

colitis

2,231

pneumonitis

2,160

asthenia

2,072