New Lung Cancer Pill By AstraZeneca Wins Early FDA Approval

This is an earlier approval than what analysts had forecasted, and if all goes well, AstraZeneca will make Tagrisso available as soon as possible to USA patients eligible to take it. Pricing, the firm said, would be “comparable” to the cost of other oral cancer therapies. This treatment has the potential to become the standard of care for patients living with EGFRm T790M non-small cell lung cancer.

The drug, called Tagrisso, which the company had labeled as AZD9291 during development, is the first drug for a subset of lung cancer patients whose tumors have spread and developed a treatment-resistant mutation, called T790M. The majority of patients have a form of the disease known as non-small cell lung cancer, of which around 10% develop a mutation in a gene known as EGFR. And now the drug, to be marketed as Tagrisso, will be put to the market test to see if it can live up to Soriot’s $3 billion peak sales estimate while staring down a strong rival in late-stage development at Clovis Oncology.

Lung most cancers is the main reason behind most cancers dying within the US, in keeping with the Facilities for Illness Management and Prevention. However, according to Reuters, industry analysts give a more cautious outlook, pointing to revenues of $1.1 billion by 2020.

AstraZeneca has “deep-rooted heritage” in the therapeutic area of oncology. Tagrisso is an EGFR-TKI, a targeted cancer therapy, created to inhibit both the activating, sensitising mutations (EGFRm), and T790M, a genetic mutation responsible for EGFR-TKI treatment resistance.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Its five years survival rate is less than 20%. Almost two-thirds of NSCLC patients who are EGFR mutation-positive and experience disease progression after being treated with an EGFR-TKI develop the T790M resistance mutation, for which there have been limited treatment options. It had received breakthrough status in the U.S. and has also received accelerated assessment in the European Union following its filing in the summer, as well as priority review in Japan.