AstraZeneca’s Tagrisso Receives Chemotherapy FDA Approval

AstraZeneca's Tagrisso has received FDA approval for use with chemotherapy in treating advanced lung cancer with specific mutations. This new standard improves disease progression-free survival. Tagrisso has shown considerable efficacy in various stages of lung cancer treatment, further establishing its central role in AstraZeneca's oncology portfolio. The recent trial results also highlight its potential in early-stage, unresectable lung cancer, offering significant improvements in patient outcomes.

The following article originally appeared in BioPharma Dive.

Tagrisso is at the center of AstraZeneca’s oncology resurgence. The drug, which first won approval in the U.S. in 2015, is the company’s second highest selling product, after the diabetes and kidney disease treatment Farxiga.

It has become a go-to treatment for EGFR-mutated lung cancers, which make up about 15% of the estimated 165,000 or so people who are diagnosed with non-small cell lung cancer each year. Over time, AstraZeneca has secured expanded clearance for its use earlier in metastatic treatment, as well as a role in the “adjuvant,” or after surgery, setting.

The latest approval, announced late Friday, could establish a new standard in the first-line metastatic setting. Adding chemo to Tagrisso extended progression-free survival by about nine months over Tagrisso monotherapy, results showed. The combination also appeared to work better in lowering the risk of cancer growth in the central nervous system.

The OK is also notable for Johnson & Johnson, which recently reported trial results showing a drug combination it’s developed beat Tagrisso monotherapy. Following Friday’s approval, physicians may now see Tagrisso plus chemo as the relevant comparator.

In the adjuvant setting, meanwhile, AstraZeneca recently shared data that proved Tagrisso used this way can considerably extend patient survival. The results “mandate testing for EGFR mutations in patients with early-stage non-small cell lung cancer,” said Benjamin Solomon, a medical oncologist at the Peter MacCallum Cancer Center in Australia, during a discussion of the data at a medical meeting last June.

For patients whose lung cancer is unresectable, new trial data AstraZeneca shared Monday show Tagrisso could help, too. Treatment resulted in a “statistically significant and highly clinically meaningful improvement in progression-free survival” versus placebo when given following chemoradiotherapy for Stage 3 non-small cell lung cancer.

Overall survival data favored Tagrisso, AstraZeneca said, but the results from the trial, called Laura, were not yet final.

“These highly impactful results for the Laura trial in this potentially curative early lung cancer setting further entrench Tagrisso as the backbone therapy for EGFR-mutated lung cancer,” said Susan Galbraith, head of oncology R&D at AstraZeneca, said in a statement.

For more, please find the original story source here.