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SMC says ‘yes’ to ultra-orphan medicine for rare type of lung cancer

Scottish Medicines Consortium recommends Alecensa®▼(alectinib) which more than triples progression free survival compared to current standard of care[i]


13 August 2018, Welwyn Garden City – Scottish patients with untreated, advanced non-small-cell lung cancer (NSCLC) whose tumours are identified as ALK-positive will have a new treatment option available via NHS Scotland funding from today.[ii] The treatment, alectinib, has been shown to improve outcomes compared to current standard of care, including decreasing the risk of disease progression or death by more than half, and by reducing the risk of tumours in the central nervous system (CNS) by 84%.[iii] This is important for both clinicians and patients alike, as the incidence of brain metastases is high in this patient group.[iv]


Dr Brian Clark, Consultant in Clinical Oncology, at Gartnavel General Hospital said, “ALK-positive NSCLC is a rare type of lung cancer that predominantly affects the younger, non-smoking population. In up to 50% of cases, the cancer has spread to the brain at the time of diagnosis. Alectinib has demonstrated improvements in delaying cancer growth in these patients and, importantly, has also shown significant improvements in preventing and delaying cancer spread into the brain. This is welcome news for patients and clinicians across Scotland, where lung is the most common cancer.”


The decision follows NICE’s approval in this indication for patients across England and Wales.[v] Alectinib meets the SMC’s ultra-orphan criteria,2 which identifies a medicine used to treat an extremely rare condition with a prevalence of 1 in 50,000 or less (or around 100 people in Scotland).[vi] The advice is conditional to commercial agreement with NHS Scotland and Roche.


Simon Eayrs, Cancer Immunotherapy Lead for Roche UK commented, “We are delighted that patients with this rare type of lung cancer will be eligible to access alectinib via NHS Scotland. This announcement is testament of our commitment to work together with the SMC to give people living with advanced forms of this rare type of lung cancer a new treatment option.”


The SMC’s decision was based on primary data analysis from the global phase III ALEX study where alectinib demonstrated statistically significant superiority vs crizotinib. Results showed alectinib reduced the risk of disease progression or death by 53% (HR 0.47, 95% CI 0.34–0.65, p<0.0001)3. The median progression free survival with alectinib was not reached, compared to 11.1 months for crizotinib, during a median follow-up of 18.6 months and 17.6 months, respectively.3 Alectinib reduced the risk of tumours spreading to, or growing in the central nervous system (CNS) compared with crizotinib by 84% (HR = 0.16; 95% CI: 0.10, 0.28; p< 0.0001),3 12 per cent of patients in the alectinib group had an event of CNS progression compared to 45% in the crizotinib group.3 Grade 3/5 AEs were less frequent with alectinib, 41%, vs 50% with crizotinib; fatal AEs occurred in 3% vs 5%, respectively.3


Prior to this approval, Roche provided alectinib via the Early Access to Medicines Schemes (EAMS), which allows patients and doctors access to promising new unlicensed medicines that have a high unmet clinical need before official approval is obtained.4 Eligible previously untreated patients with NSCLC whose tumours are identified as ALK-positive will be able to access the medicine via NHS Scotland routine funding from today.

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Last Updated: 14-Aug-2018