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Investing.com -- AstraZeneca (NASDAQ:AZN) on Monday night received accelerated approval from the U.S. Food and Drug Administration (FDA) for its lung cancer drug Datroway.
The approval covers use in patients with EGFR-mutated non-small cell lung cancer who are no longer responding to EGFR therapy.
The FDA decision, which arrived slightly ahead of the July 12 PDUFA date, helps “de-risk what we see as a $0.5bn peak in-market sales opportunity,” according to analysts at JPMorgan.
The approval had been viewed as uncertain due to mixed results from the TL-01 study, but AstraZeneca revised the filing to include a subgroup analysis from the TL-05 trial and limited the indication to EGFR-mutated patients.
This is the second approved indication for Datroway, following its earlier approval for refractory hormone receptor-positive breast cancer. That prior approval already “de-risks a c$0.4bn peak in-market sales potential,” the analysts noted.
“We see the approval as a minor positive for Astra shares, and we note the approval comes slightly ahead of the July 12th PDUFA deadline, and some investors had seen a risk of a delay, ODAC or request for further data,” JPMorgan analysts led by James D. Gordon said in a note.
The next major catalyst for Datroway is Phase III data from the TB02 study in triple-negative breast cancer, expected this quarter, which JPMorgan sees as a potential $1 billion sales opportunity.
A more significant test will come later in the year with Phase III AVANZAR data in first-line lung cancer.
While the analysts acknowledge modest expectations due to earlier trial results and changes in study design, they highlight that “we now see good risk reward into this readout at the end of the year.”
Overall, consensus currently models risk-adjusted Datroway sales of about $5 billion across indications.
JPMorgan believes the market remains cautious on peak sales potential, limiting downside risk if upcoming data disappoint, while leaving room for substantial upside in the event of positive results.