Home / Press Release / FDA approves AstraZeneca PLC’s Tagrisso cancer drug

FDA approves AstraZeneca PLC’s Tagrisso cancer drug

United States Food and Drug Administration has approved a potential $33 billion cancer drug Tagrisso developed by AstraZeneca PLC (NASDAQ:AZN) under the FDA’s accelerated approval process based on tumor response rate and duration of response (DoR), along with the approval of an accompanying diagnostic.

In 2 clinical trials that were conducted, partial or whole decrease was experienced by 57 percent and 61 percent of patients within the size of their tumor. The side effects that were seen were skin and fingernail issues and diarrhea. Mainly, cancer related death in the US is caused owing to lung cancer and there are estimates of 221,200 new diagnoses and 158,040 deaths in the year 2015 as per National Cancer Institute.

Most sufferers have a kind of illness that is known as non-small cell lung cancer. Mutation is developed by around 10 percent in a gene which is known as EGFR. An accompanying diagnostic was also approved by FDA for testing the mutation that is targeted by Tagrisso. With this newly approved version, the T790M mutation is added to clinically relevant mutations that the Cobas EGFR Mutation test detected.

The availability of this drug would be seen in the United States soon and the price can be compared to other therapies of oral cancer. Almost 2/3rd of NSCLC patients who are tested positive for EGFR mutation develop the T790 resistance mutation. There are very limited options for treatment.

“Our understanding of the molecular basis of lung cancer and reasons these cancers become resistant to prior treatments is rapidly evolving,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This approval provides a new treatment for patients who test positive for the EGFR resistance mutation, T790M, and is based on substantial evidence from clinical trials that shows Tagrisso had a significant effect on reducing tumor size in over half of patients who were treated.”

This has been followed by the recent launch of Lynparza by AstraZeneca for ovarian cancer. The company has been brought closer to the goal of brining 6 new treatments of cancer for marketing by the year 2020. Due to these encouraging results that are provided by medical trials, a breakthrough status was given by the drug and an accelerated assessment was granted. This means that there was a priority review in many countries including Europe, Japan and United States.

The path of Tagrisso has been quite fast and it took just 2 and a half years from the start of clinical trials for approval in the top drugs market of the market.  The new drug is termed as Tagrisso but osimertinib is the actual chemical contained in it.  AstraZeneca PLC (Nasdaq: AZN) markets Tagrisso.

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