AstraZeneca and HUTCHMED’s savolitinib has been granted conditional approval in China for the treatment of patients with non-small cell lung cancer (NSCLC).
The treatment is for patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
Approximately 2-3% of newly diagnosed NSCLC patients have MET exon skipping 14 alterations, a specific genetic mutation.
The approval by China’s National Medical Products Administration was based on positive Phase II trial results conducted in patients with NSCLC with this mutation, including patients with the more aggressive pulmonary sarcomatoid carcinoma subtype.
Savolitinib demonstrated effective anti-tumour activity based on an independent review of objective response rate and disease control rate. The approval is conditional upon successful completion of a confirmatory study in this patient population.
Dave Fredrickson, Executive Vice President, Oncology Business Unit of AstraZeneca, said: “This approval makes savolitinib the only targeted medicine approved for these biomarker-selected patients in China, and it adds another novel medicine to our already diverse lung cancer portfolio.
“We are proud that this first-ever regulatory approval of savolitinib is in China, where we have a long-standing commitment to improving patient outcomes and working with the right partners to achieve that goal.
Alongside HUTCHMED, we look forward to the continued development of this medicine across a range of cancers where MET alterations and amplification are drivers of tumour growth and treatment resistance.”
Christian Hogg, Chief Executive Officer of HUTCHMED, said: “It is with great pleasure that today we announce the first regulatory approval of savolitinib globally, HUTCHMED’s third self-discovered oncology drug to be commercialised.
“Our collaboration with AstraZeneca in 2011 has been an important driver in the development of this novel targeted oncology drug, involving both a China-based biotech and a global pharma company.
“This approval is a testament to the perseverance and scientific ingenuity of this long-standing alliance, and we are hopeful that this is only the beginning of the progress we can achieve for patients with MET-altered tumours.”
Savolitinib is an oral, potent, and selective MET TKI that has demonstrated clinical activity in advanced solid tumours.
It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations).
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