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News & Trends - Pharmaceuticals

First targeted therapy approved for early stage lung cancer

Health Industry Hub | June 2, 2021 |
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Pharma News: The first targeted treatment is Therapeutic Goods Administration (TGA) approved for early stage, epidermal growth factor receptor (EGFR) mutated, resectable non-small cell lung cancer (NSCLC).

AstraZeneca’s oral Tagrisso (osimertinib) approval was based on results from the ADAURA Phase III trial where Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the primary analysis population of patients with Stage II and IIIA EGFRm NSCLC, and also in the overall trial population of patients with Stage IB-IIIA disease, a key secondary endpoint.

Associate Professor Tom John, Medical Oncologist at Peter MacCallum Cancer Centre, said “Osimertinib is a targeted therapy that is an option for specific patients whose lung tumours have an EGFR mutation. The more options we have enables us to better personalise treatments for those most likely to benefit.”

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In the ADAURA trial, adjuvant treatment with Tagrisso reduced the risk of disease recurrence or death by 83% in patients with Stage II and IIIA disease (p<0.001) and by 80% in the overall trial population of patients with Stage IB-IIIA disease (p<0.001).

Mark Brooke, Lung Foundation Australia Chief Executive Officer, said “In the last 20 years, lung cancer mortality rates have decreased more than any other cancer. Early detection and equitable access to new treatments is what those Australians diagnosed with lung cancer each year, their carers and families, have long campaigned for. Ultimately, advancements such as this will provide another treatment option for one of Australia’s leading causes of cancer death,” he said.

Liz Chatwin, Country President, AstraZeneca Australia & New Zealand, said, “We are pleased that for the first time, a targeted treatment option is approved for Australians living with early-stage EGFR-mutated NSCLC following surgery. This approval demonstrates our focus to prevent disease recurrence and reduce mortality for patients with lung cancer.

“AstraZeneca intends to seek Pharmaceutical Benefits Scheme (PBS) listing for Tagrisso. We are committed to working with the Pharmaceutical Benefits Advisory Committee to make Tagrisso accessible in this setting.”

Tagrisso is approved to treat early-stage lung cancer in more than a dozen countries, including the US, and additional global regulatory reviews are ongoing. Tagrisso is also approved for the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC in Australia, China, US, Japan, EU and many other countries

Lung cancer continues to be one of Australia’s biggest cancer killers, with one of the lowest survival rates of any major cancer type in Australia. Last year, lung cancer was the most common cause of cancer death, with an estimated 13,258 new cases, and claiming the lives of approximately 8,641 Australians.

Disease recurrence is still common in early-stage NSCLC. Over a median follow-up of approximately 5 years, the percentage of patients who have disease recurrence or who die after surgery, with or without adjuvant chemotherapy, remains high – ranging from 45% among patients with stage IB disease, to 76% among those with stage III disease.

What is more concerning, approximately 68% of NSCLC recurrences following surgery involve distant metastases, with 41% occurring in the brain, highlighting the need for additional treatment options for these patients.

NSCLC, the most common type of lung cancer, accounts for more than eight in 10 cases, and occurs when cancer cells form in the tissues of the lung. Approximately 17% of NSCLC cases are linked to a specific gene mutation known as EGFR.


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