AstraZeneca's (AZN) Imfinzi Gets FDA Nod for Label Expansion

AstraZenecaAZN announced that the FDA has approved a second indication for its PD-L1 inhibitor, Imfinzi. It is now approved for unresectable Stage III non-small cell lung cancer ("NSCLC"). The drug is meant for patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

AstraZeneca's shares have returned 16.3% in the past year, outperforming the industry 's gain of 13% in that period.

The approval comes on the back of impressive progression free survival data ("PFS") in patients treated with Imfinzi in the phase III PACIFIC study. Data showed that Imfinzi improved PFS by more than 11 months in comparison to placebo in the concerned patient population. The median PFS was 16.8 months for patients on Imfinzi compared with 5.6 months for placebo.

Imfinzi was launched in the United States for the first indication - second line advanced bladder cancer - in May 2017. The drug has brought in sales of $19 million in 2017.

Per the press release, globally 30% of NSCLC patients have Stage III disease with the majority of the patients diagnosed with unresectable tumors. Currently, the patients are treated with chemotherapy and radiation therapy, followed by active surveillance to monitor for progression. Imfinzi, the first immunotherapy approved in this indication, will be a better treatment option for these patients and represents a better market opportunity for AstraZeneca.

AstraZeneca is also developing Imfinzi as monotherapy as well as combination therapy for treatment of NSCLC in first-line or adjuvant setting. The drug is also being developed for several other cancer indications including head and neck, gastric, pancreatic, hepatocellular and blood cancers.

However, lung cancer is a competitive segment as it attracts several players due to the huge market opportunity. Novartis NVS and Roche received approval for their respective drugs, Zykadia and Alecensa, in 2017 for treating metastatic NSCLC in first-line setting.

Other immunotherapies for treating various cancer indications include Bristol-Myers Squibb Company's BMY Opdivo and Merck & Co.'s MRK Keytruda.

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