AstraZeneca plc. (AZN - Free Report) announced that the European Commission has granted marketing approval to its immunotherapy Imfinzi for an early-stage lung cancer indication.
The PD-L1 inhibitor was approved as a monotherapy for patients with locally-advanced, unresectable (stage III) non-small cell lung cancer (NSCLC), whose disease has not progressed following platinum-based chemotherapy concurrent with radiation therapy (CRT). Stage III NSCLC represents approximately one-third of NSCLC incidence globally with the only treatment available for years being chemoradiation therapy.
The approval was based on positive progression free survival data from the phase III PACIFIC study. The approval was expected as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had given a positive opinion recommending marketing approval to Imfinzi for the disease.
Imfinzi is already approved for this indication in many countries including the United States and Japan. Imfinzi was approved and immediately launched for this indication in the United States in February, which drove sales in the first half. Imfinzi recorded sales of $184 million in the first half of 2018. The lung cancer indication accounted for the majority of sales in the second quarter after approval in February. With the latest approval in EU and in Japan in July, sales of the drug should be higher in the future quarters.
AstraZeneca’s shares have gained 9.1% so far this year, outperforming an increase of 7.1% for the industry.
Other than the lung cancer indication, Imfinzi is also marketed for second-line advanced bladder cancer in several countries. Imfinzi (durvalumab) is also being evaluated for multiple other cancers (either alone or in combination with other regimens) and has bright long-term prospects.
The demand for checkpoint inhibitors, especially those targeting PD-1 and PD-L1 has risen significantly in the past couple of years. It is estimated that their market will rise tremendously in the next four to five years. PD-1 and PD-L1 are proteins present on the surface of cancer cells. Other PD-L1 inhibitors on the market are Merck’s (MRK - Free Report) Keytruda, Bristol Myers’ (BMY - Free Report) Opdivo, Roche’s Tecentriq and Pfizer’s (PFE - Free Report) Bavencio.
In a separate press release, AstraZeneca announced that the CHMP has recommended inclusion of cardiovascular outcomes data from the EXSCEL study in the European label of its type-II diabetes medicine, Bydureon. Data from the study presented in May showed that Bydureon did not increase the risk of major adverse cardiovascular events (MACE) compared to placebo and showed a consistent safety profile. MACE is a composite endpoint of CV death, non-fatal myocardial infarction or non-fatal stroke.
Meanwhile, fewer CV events were observed in the Bydureon arm. However, the efficacy objective of a superior reduction in CV risk did not reach statistical significance. Please note that CHMP’s positive opinion can be implemented without the need for an immediate European Commission decision as it is a Type-II variation update.
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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