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AstraZeneca beats second quarter estimates and reiterates guidance / Image source: Adobe
  • Lung cancer treatment gets US approval
  • Risk of disease progression cut by 38%
  • Lung cancer a leading cause of deaths

Shares in AstraZeneca (AZN) topped the FTSE 100 leaderboard on Monday after the pharmaceutical firm said its lung cancer drug Tagrisso has been approved by the US regulator for treating patients with advanced non-small cell lung cancer (NSCLC).

The shares gained 3% to £104.38, partially reversing the downtrend seen over the last six months where they have lagged the blue-chip index by around 8%.

STRONG EFFICACY 

Approval follows a priority review by the US Food and Drug Administration based on results from a late-stage trial which showed Tagrisso plus chemotherapy reduced the risk of disease progression by 38% compared with the current standard of care.

Patients treated with the combined therapy achieved a median 25.5 months of PFS (progression free survival) which is an 8.8-month improvement on the current 16.7 delivered by the current standard of care.

Dave Fredrickson, executive vice president of AstraZeneca’s oncology business, commented: ‘This important new treatment option can delay disease progression by nearly nine additional months, establishing a new benchmark with the longest reported progression-free survival benefit in the 1st-line advanced setting. 

‘This approval reinforces Tagrisso as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy. 

‘This news is especially important for those with a poorer prognosis, including patients whose cancer has spread to the brain and those with L858R mutations.’

LEADING CAUSE OF CANCER DEATHS

Lung cancer is the leading cause of cancer death among women and men accounting for approximately one fifth of all cancer deaths, the company said.

Over 200,000 people in the US are diagnosed with lung cancer each year of which 80% to 85% are diagnosed with non-small cell lung cancer. Approximately 75% of people are diagnosed with advanced lung cancer.

The company said Tagrisso is the only targeted therapy to improve patient outcomes in both early and late-stage lung cancer. In 2023 the drug generated sales of $1.47 billion, up 6% on the prior year.

Separately, the company announced that a biologics license application for datopotamab deruxtecan in conjunction with Japanese partner Daiichi Sankyo (4568:TYO) has been accepted in the US for treating adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer who have received prior systemic therapy.

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Issue Date: 19 Feb 2024