AstraZeneca secures MHRA licensing and NHS early access for lung cancer drug

pharmafile | May 7, 2021 | News story | Medical Communications Astrazenaca, oncology 

AstraZeneca have announced that the MHRA has granted a license extension for Tagrisso (osimertinib) in the UK, for use as monotherapy for the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC), whose tumours have epidermal growth factor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.

An agreement has also been made with NHS England and NICE to enable early access to osimertinib for all patients in England with this specific type of lung cancer, with access given ahead of official NICE guidance to ensure patients have the chance to benefit from this new treatment option as soon as possible.

This is the first authorisation to be issued by the MHRA under Project Orbis, a global programme designed to deliver faster patient access to innovative cancer treatments led by the FDA.

Project Orbis includes regulatory authorities of, Australia (TGA), Canada (Health Canada), Singapore (HSA), Switzerland (Swissmedic), and Brazil (ANVISA).

Arun Krishna, Head of Oncology at AstraZeneca UK, said: “Patients diagnosed in the earlier stages of EGFR mutation-positive non-small cell lung cancer have the best chance of living disease-free, but many see their cancer return.

“Osimertinib, which was discovered by AstraZeneca scientists in the UK, could significantly improve patient outcomes in a disease setting that has had no new treatment options in over a decade. With this in mind, we have worked with urgency to secure the MHRA license and access in England to bring this treatment option to patients as quickly as possible.”

The standard of care for patients with early-stage lung cancer is surgery with curative intent, followed by adjuvant chemotherapy in appropriate patients. Despite this, disease recurrence within five years of surgery remains high, and has been reported to occur in 45% of stage IB, 62% of stage II, and 76% of stage III patients.

Data from the phase III ADAURA trial investigating osimertinib show a reduction in the relative risk of disease recurrence or death by 83% compared to placebo.

Data from ADAURA also show that, at two years in patients with stage IB-IIIA disease, 89% of patients treated with osimertinib after surgery remained alive and disease-free versus 52% on placebo.

Osimertinib is also licensed in the United Kingdom as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations and also for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

Dr Carles Escriu, Consultant in Thoracic Medical Oncology at The Clatterbridge Cancer Centre NHS Foundation Trust in Liverpool, said: “Today’s news is potentially practice-changing because, for the first time, we have access to a targeted treatment for early-stage lung cancer.

“Osimertinib is a well-tolerated, once-daily tablet treatment and data show that, when taken after surgery, it can reduce the risk of disease recurrence or death by 80% after two years of treatment in patients with Stage IB-IIIA non-small cell lung cancer who have an EGFR mutation. Early-stage lung cancer patients can now be tested for EGFR mutations to give them the chance of delaying the return of cancer after surgery.”

Kat Jenkins

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