'Breakthrough' status issued by FDA for Tagrisso and pevonedistat

UK-based AstraZeneca’s (LSE: AZN) says that its Tagrisso (osimertinib) has been granted Breakthrough Therapy designation (BTD) in the USA for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent.

Tagrisso is already an important growth driver for AstraZeneca in its current cancer indications, and generated sales of $1 billion in the second quarter of this year, a year-on-year increase of 32%.

While up to 30% of patients with NSCLC may be diagnosed early enough to have potentially curative surgery, disease recurrence is common in early-stage disease and nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, experience recurrence within five years.1-6