Regulatory updates on Imfinzi and Tagrisso in Europe and USA

Shares in AstraZeneca (LSE: AZN) edged higher in early dealing today, on the news that US regulators have granted its Tagrisso (osimertinib) Breakthrough Therapy designation and its European peer has accepted the marketing application for its Imfinzi (durvalumab).

The Anglo-Swedish pharma major, along with its biologics R&D arm MedImmune, revealed  that the European Medicines Agency has accepted a Marketing Authorization Application (MAA) for Imfinzi for the treatment of patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. This is the first registrational submission for Imfinzi in the European Union.

The MAA submission acceptance is an important milestone for Imfinzi in a disease state where patients need better treatment options and outcomes. Currently, the standard of care for patients with this earlier stage of lung disease is active monitoring following concurrent chemoradiation.

The MAA submission is based on positive progress-free survival (PFS) data from the Phase III PACIFIC trial. The trial continues to evaluate overall survival (OS), its other primary endpoint. Detailed results of the PACIFIC trial, including additional safety information, were published online in the New England Journal of Medicine.

Imfinzi has already received accelerated approval in the USA for the treatment of patients with locally-advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

Earlier this year AstraZeneca suffered a significant setback when the initial results of the Phase III MYSTIC trial with Imfinzi were a big disappointment. The trial is continuing and, while some analysts have said they do not regard MYSTIC success as essential to AstraZeneca’s turn-round strategy, unimpressive results on overall survival would be a blow. Berenberg, the investment bank, this year estimated potential annual sales for Imfinzi, should the trial deliver strong results, at $2.5 billion.

Breakthrough status for Tagrisso as first-line NSCLC therapy

AstraZeneca also today announced that the US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).

The drug is currently approved in more than 50 countries, including the USA, Japan, China and Europe, as a second-line treatment for patients with advanced NSCLC. The market for NSCLC therapies is expected by some analysts to grow to around $13 billion by the year 2024.Tagrisso generated sales of $232 million in the second quarter of this year.

Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said: “The Breakthrough Therapy Designation acknowledges not only Tagrisso’spotential as a 1st-line standard of care in advanced EGFR mutation-positive NSCLC, but also the significant need for improved clinical outcomes in this disease. The results of the FLAURA trial have the potential to redefine clinical expectations and offer new hope for patients who currently have a poor prognosis.”

This is the sixth BTD that AstraZeneca has received from the FDA for an oncology medicine since 2014. BTD is designed to expedite the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which demonstrate substantial improvement on a clinically-significant endpoint over available medicines and when there is significant unmet medical need.


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