Regulatory Focus™ > News Articles > UK Patients With NSCLC to get Early Access to Tagrisso

UK Patients With NSCLC to get Early Access to Tagrisso

Posted 07 December 2015 | By Michael Mezher 

UK Patients With NSCLC to get Early Access to Tagrisso

Patients in the UK with a specific form of non-small-cell lung cancer (NSCLC) will get early access to AstraZeneca's Tagrisso (osimertinib), following a positive opinion by the Medicines and Healthcare products Regulatory Agency (MHRA).

Specifically, patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC will be able to access Tagrisso under the Early Access to Medicines Scheme (EAMS).

EAMS was created to provide faster access to new products designated to treat "life-threatening or seriously debilitating conditions … where there is a clear unmet medical need."

To date, three other drugs have been granted positive EAMS opinions:

To qualify for EAMS, a product must first receive a promising innovative medicine (PIM) designation from MHRA, based on early (Phase I and/or II) clinical data showing the product's benefits outweigh its risks. After receiving a PIM designation, a sponsor can submit its product to MHRA for a scientific review under EAMS. Once a medicine is given a positive EAMS opinion, it is commissioned by the National Health Service (NHS) and provided to patients free of charge.

Tagrisso is currently being reviewed by the European Medicines Agency (EMA), and was granted Breakthrough Therapy designation in the US before being approved by the Food and Drug Administration (FDA) in November.

MHRA says it gave Tagrisso a positive EAMS opinion after determining that the drug showed promise in shrinking patients' tumors, with mostly moderate side effects. The agency also said that patients with the EGFR T790M mutation-positive lung cancer "have very limited treatment options, reduced life expectancy and … an urgent need for more therapies."

However, Tagrisso is not without risks, the most common known side effects for the drug are diarrhea, rash and dry skin; and some patients experienced drops in blood cell counts and a sometimes fatal condition called interstitial lung disease.


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