On 29 January 2026, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended authorisation of BMS’s Opdivo® (nivolumab) in combination with brentuximab vedotin for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy.

Opdivo® has been approved in the EU for several other indications including a subcutaneous formulation for various solid tumours; non-small cell lung cancer; melanoma; gastric, gastroesophageal junction, or oesophageal adenocarcinoma; and in combination with Yervoy® for unresectable or advanced hepatocellular carcinoma;  microsatellite instability–high or mismatch repair deficient unresectable or metastatic colorectal cancer.

A number of nivolumab biosimilars are in development, with Zydus recently being first to market its biosimilar, Tishtha®, in India.  Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius, Enzene, Reliance Life Sciences and Biocon have nivolumab biosimilars in their pipelines.

On 27 and 28 May 2025, Bristol Myers Squibb announced that its subcutaneous formulation of Opdivo® (nivolumab), Opdivo® SC (nivolumab co-formulated with recombinant human hyaluronidase (rHuPH20)), has been approved in Europe and Canada across multiple solid tumour indications in monotherapy, in the maintenance phase following combination with ipilimumab (Yervoy®), and in combination regimens with chemotherapy.

The European approval follows the CHMP recommendation earlier in May 2025.  The EU and Canada join the US and UK in approving the subcutaneous formulation.

At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development or in contemplation.

On 16 May 2025, Bristol Myers Squibb announced that the European Commission (EC) has approved the perioperative regimen of neoadjuvant Opdivo® (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo® for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥1%.

This follows the March 2025 CHMP recommendation for the indication.  At its March 2025 meeting, the CHMP also recommended the approval of a new Opdivo® formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial).  Subcutaneous Opdivo® has previously been approved in the US (December 2024) and the UK (April 2025) for most but not all previously approved adult, solid tumour indications.

At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development or in contemplation.

At its March meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted positive opinions for seven indication expansions, including to:

• BMS’ Opdivo® (nivolumab) in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo® as monotherapy as adjuvant treatment, for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumours have PD-L1 expression at or higher than 1%.
• Janssen’s Tremfya® (guselkumab) for treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment; and
• Beigene’s Tevimbra® (tislelizumab) in combination with etoposide and platinum chemotherapy, for first-line treatment of adults with extensive-stage SCLC.

The CHMP also recommended the approval of a new Opdivo® formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial).  Subcutaneous Opdivo® has previously been approved in the US for most but not all previously approved adult, solid tumour indications.

On 7 March 2025, Bristol Myers Squibb (BMS) announced that the European Commission has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first line treatment of adults with unresectable or advanced hepatocellular carcinoma (HCC).  The EC approval follows the CHMP’s positive opinion for the expanded indication in January 2025.

The same indication for the Opdivo®/Yervoy® combination is currently under review by the FDA, with BMS’ sBLA accepted in August 2024.  The FDA assigned a PDUFA goal date of 21 April 2025.

In December 2024, the European Commission approved Opdivo®/Yervoy® for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC).  Applications for this indication are also pending in countries including the US (sBLA accepted in February 2025), Australia (TGA application filed in July 2024) and Japan (supplemental application filed in September 2024).

At its January 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for four new medicines and expanded indications for eight.

The new medicines include AstraZeneca/Daiichi Sankyo’s Datroway® (datopotamab deruxtecan) for patients with unresectable or metastatic hormone receptor (HR)-positive, HER2- negative breast cancer who have received endocrine therapy and at least an additional line of chemotherapy in the advanced setting.  Datroway® was approved in the US for the same indication in mid-January 2025 and in Japan in December 2024.  However, in December 2024, AZ/Daiichi voluntarily withdrew their European marketing authorisation application for the NSCLC indication of Datroway® based on CHMP feedback.  Daiichi Sankyo and AstraZeneca are jointly developing and commercialising the product pursuant to an agreement entered in July 2020, with Daiichi being the sponsor in Europe.

Pfizer’s Tivdak® (tisotumab vedotin) also received a positive opinion at the January CHMP meeting for treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.

The eight CHMP-recommended indication expansions included those for AZ’s Imfinzi® (durvalumab), for treatment as monotherapy of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy; BMS’ Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma; and Roche’s Ronapreve® (casirivimab/imdevimab) for COVID-19 in children.

Three biosimilars received positive opinions from CHMP at the January meeting as reported here.

On 23 December 2024, following the November 2024 recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), the European Commission has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC).

Applications for approval of this combination for treatment of colorectal cancer have also been made in Australia (July 2024) and Japan (September 2024).

At the November 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation under exceptional circumstances for InflaRx’s Gohibic® (vilobelimab) for treatment of adults with SARS-CoV2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids.  A marketing authorisation under exceptional circumstances is recommended when the benefit/risk assessment is positive but where the rarity of the disease means it is unlikely that comprehensive data can be obtained under normal conditions of use.

The CHMP also recommended the following indication extensions:

• MSD’s Keytruda® (pembrolizumab), in combination with pemetrexed and platinum chemotherapy for first-line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma;
• BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab), in combination, for mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer in first-line treatment of unresectable or metastatic colorectal cancer or for treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy;
• Janssen’s Rybrevant® (amivantamab), in combination with lazertinib, for first-line treatment of adult patients with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 l858R substitution mutations;
• Sanofi’s Kevzara® (sarilumab), in a new strength (175mg/ml solution for injection in vial), for active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older, who have responded inadequately to previous therapy with conventional synthetic DMARDs, as monotherapy or in combination with MTX; and Sarclisa® (isatuximab), in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant;
• Regeneron/Ultragenyx’s Evkeeza® (evinacumab) as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and paediatric patients aged 6 months and older with homozygous familial hypercholesterolaemia.

Four biosimilars also received positive opinions at CHMP’s November meeting; two Samsung Bioepis denosumab biosimilars (reported here) and two aflibercept biosimilars for Formycon/Klinge (reported here).

In addition, the CHMP adopted a positive opinion for Eisai’s Leqembi® (lecanemab), as reported here.

Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its type II variation application for Opdivo® (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.  This validation of the application confirms the submission is complete.

On 22 August 2023 the European Commission expanded the indication for Opdivo® as a monotherapy for adjuvant treatment of patients over 12 with stage IIB or IIC melanoma who have undergone complete resection.

BMS announced that the European Commission has expanded the indication for its Opdivo® (nivolumab) as a monotherapy for adjuvant treatment of patients over 12 with stage IIB or IIC melanoma who have undergone complete resection.  Opdivo® is now the only PD-1 inhibitor that is indicated to treat stages IIB, IIC, III, and IV resected melanoma.

On 21 July 2023, the CHMP issued a positive opinion for BMS’s Opdivo® (nivolumab) to treat completely resected stage IIB or IIC melanoma.