RYBREVANT®▼(amivantamab) in combination with carboplatin and pemetrexed is accepted for use within NHS Scotland as a first-line treatment for adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations

High Wycombe, UK (8 December 2025) – Johnson & Johnson welcomes the decision made today by the Scottish Medicines Consortium (SMC) to accept RYBREVANT^®▼ (amivantamab) in combination with carboplatin and pemetrexed for use within NHS Scotland for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations.^[1]

Lung cancer is the third most common cancer in Scotland, with around 5,300 people diagnosed each year, and NSCLC accounts for 80-85 percent of all cases.^[2],[3] EGFR exon 20 insertion mutations are associated with poorer outcomes compared to other more common EGFR mutations.¹ There has been a significant unmet need for new, targeted treatment options for this group of patients, whose cancer is often resistant to other NSCLC treatments.^1,[4]

“EGFR+ UK is delighted that the Scottish Medicines Consortium has approved amivantamab with chemotherapy for eligible patients in Scotland diagnosed with EGFR Exon 20 insertion mutations NSCLC,” said Prof. Virginia Harrison, Research Trustee, EGFR+ UK.* “This announcement marks a landmark moment for a group of patients who have long faced limited and often ineffective treatment options. Today’s decision changes that. It gives eligible patients and families a treatment option that truly targets their cancer from day one. This is an important and emotional moment for the patient community, and we’re really grateful to everyone who helped make this progress possible.”

This milestone marks important progress in ensuring that adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations are offered treatment pathways that reflect the underlying biology of their disease.

“The approval is very welcome news and an important advance in the treatment of patients with lung cancer in Scotland. This is the first targeted therapy available in Scotland specifically approved as a first-line treatment for patients with this uncommon subtype of lung cancer, where treatment options until now have been quite limited,” said Dr. Brian Clark, Consultant Clinical Oncologist in Scotland. 

The SMC’s recommendation is based on data from the Phase 3 PAPILLON study, which found that amivantamab with carboplatin and pemetrexed increased median progression-free survival (PFS) by blinded independent committee review (BICR) – the study’s primary endpoint – by 4.7 months (11.4 months versus 6.7 months) compared to carboplatin and pemetrexed alone.^1,4 In the dataset of amivantamab in combination with carboplatin and pemetrexed (N=301), the most frequent adverse reactions in all grades were rash (83 percent, neutropenia (57 percent), nail toxicity (53 percent), infusion related reactions (IRR) (51 percent), fatigue (43 percent), stomatitis (39 percent), nausea (43 percent), thrombocytopenia (40 percent), constipation (40 percent), oedema (40 percent), decreased appetite (33 percent), hypoalbuminaemia (32 percent), alanine aminotransferase increased (26 percent), aspartate aminotransferase increased (23 percent), vomiting (22 percent), and hypokalaemia (20 percent).^[5] Serious adverse reactions included rash (2.7 percent), venous thromboembolism (2.3 percent), thrombocytopenia (2.3 percent) and interstitial lung disease (ILD) (2.0 percent).⁵ 8 percent of patients discontinued amivantamab due to adverse reactions. The most frequent adverse reactions leading to treatment discontinuation were IRR (2.7 percent), rash (2.3 percent), ILD (2.3 percent), and nail toxicity (1.0 percent).⁵

“The availability of targeted treatment options is crucial for people living with lung cancer driven by specific mutations. We are therefore delighted to have secured access for eligible patients in Scotland to a first-line treatment targeting EGFR exon 20 insertion mutations, which will make a real difference to these patients’ lives,” said Amanda Cunnington, UK Senior Director of Patient Access, Johnson & Johnson Innovative Medicine. “We are grateful to all involved in the appraisal that led to this positive outcome, and remain committed to partnering with NHS Scotland to ensure swift access for eligible patients.”

[1] SMC. Amivantamab (Rybrevant). Available at https://scottishmedicines.org.uk/medicines-advice/amivantamab-rybrevant-fasttrackresub-smc2878. Last accessed December 2025.

[2] Public Health Scotland. Cancer incidence and prevalence in Scotland. To December 2023. Available at https://publichealthscotland.scot/media/35152/20250930-cancer-incidence-2023-report-finalv.pdf. Last accessed December 2025.

[3] Cancer Research UK. Types of Lung Cancer. Available at https://www.cancerresearchuk.org/about-cancer/lung-cancer/stages-types-grades/types. Last accessed December 2025.

[4] Zhou C, Tang KJ, Cho BC, Liu B, Paz-Ares L, Cheng S, Kitazono S, Thiagarajan M, Goldman JW, Sabari JK, Sanborn RE, Mansfield AS, Hung JY, Boyer M, Popat S, Mourão Dias J, Felip E, Majem M, Gumus M, Kim SW, Ono A, Xie J, Bhattacharya A, Agrawal T, Shreeve SM, Knoblauch RE, Park K, Girard N; PAPILLON Investigators. Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions. N Engl J Med. 2023;389(22):2039-2051.

[5] Rybrevant (amivantamab) 350mg concentrate for solution for infusion. Summary of Product Characteristics. Available at https://www.medicines.org.uk/emc/product/13084/smpc/print. Last accessed December 2025.