The combination therapy offers a new chemotherapy-free first-line option for eligible patients with 먹튀없는 바카라사이트 아톰카지노 exon 19 deletions or exon 21 L858R substitution mutations
[by Sung, Jae Jun] Johnson & Johnson has announced on December 18(local time) that the National Institute for Health and Care Excellence (NICE) has recommended RYBREVANT® (amivantamab) with LAZCLUZE™ (lazertinib), for use within its marketing authorisation, as an option for untreated advanced non-small cell lung cancer (NSCLC) in adults whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, in its Final Draft Guidance.1 This recommendation means that newly-diagnosed eligible patients may now be treated with amivantamab and lazertinib on the NHS in England and Wales.
Between 2019 and 2023, on average around 35,000 people were diagnosed with lung cancer in England.2 NSCLC is the most common type of lung cancer, accounting for 80-85 percent of all cases. 먹튀없는 바카라사이트 아톰카지노 mutations are present in around 15 percent of cases of NSCLC in European patients, and most (85-90 percent) are exon 19 deletions or exon 21 L858R substitution mutations. 먹튀없는 바카라사이트 아톰카지노-positive NSCLC is more common in women than in men, those who do not smoke and people from Asian ethnic groups.
“EGFR+ UK welcomes NICE’s approval of amivantamab plus lazertinib for first-line treatment of eligible patients with common EGFR mutated NSCLC,” said Prof. Virginia Harrison, Research Trustee, EGFR+ UK.* “This is a meaningful advance for patients and their families facing this diagnosis. Importantly, it also provides something the EGFR community urgently needs: more choice in first-line treatment. Access to multiple effective options empowers patients and clinicians to tailor care to individuals’ needs and preferences, while maximising patient outcomes. This decision represents an important step in treatment options for people with EGFR-mutated lung cancer.”
“NICE’s recommendation represents a meaningful moment for the management of EGFR-mutated advanced NSCLC,” said Professor Sanjay Popat**, FRCP, Ph.D., Medical Oncologist at the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, UK. “Access to additional first-line options on the NHS gives clinicians the flexibility to individualise treatment plans, which is essential in addressing the complex needs of this patient population. This milestone highlights the importance of continued progress in expanding treatment choice and supporting evidence-based care within the treatment pathway.”
The NICE recommendation is based on data from the Phase 3 MARIPOSA study, which met its primary endpoint of progression free survival (PFS), with patients receiving amivantamab with lazertinib living for a median of 23.7 months (95% confidence interval [CI], 19.1 to 27.7) without their disease worsening versus 16.6 months (95% CI, 14.8 to 18.5) in patients receiving osimertinib (hazard ratio for disease progression or death, 0.70; 95 percent CI, 0.58-0.85; p<0.001†). Additionally, patients receiving amivantamab with lazertinib experienced significantly improved overall survival (OS) [secondary endpoint] versus those on osimertinib (hazard ratio for death, 0.75; 95 percent CI, 0.61-0.92; p<0.005). Median OS has not yet been reached (95 percent CI, 42.9-not reached [NR]) in patients treated with the combination versus 36.7 months (95 percent CI, 33.4-41.0) for patients treated with osimertinib.
In the dataset of amivantamab (either intravenous or subcutaneous formulations) in combination with lazertinib (N=752), the most frequent adverse reactions of any grade (≥ 20 percent patients) were rash (87 percent), nail toxicity (67 percent), hypoalbuminaemia (48 percent), hepatotoxicity (43 percent), stomatitis (43 percent), oedema (42 percent), fatigue (35 percent), paraesthesia (29 percent), constipation (26 percent), diarrhoea (26 percent), dry skin (25 percent), decreased appetite (24 percent), nausea (24 percent), and pruritus (23 percent).
“Today’s Final Draft Guidance from NICE represents an important step forward for people newly diagnosed with common EGFR mutated NSCLC in England and Wales,” said Amanda Cunnington, UK Senior Director of Patient Access, Johnson & Johnson Innovative Medicine. “The availability of a chemotherapy-free combination treatment will no doubt be welcome news to eligible patients and their loved ones. We are committed to working with partners across the healthcare system to ensure timely, equitable access to innovative therapies, and to support clinicians in delivering personalised care, enabling eligible patients to access advances seen in clinical data.”