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Non-small cell lung cancer is the most common type of lung cancer, accounting for about 85% of lung cancers
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The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorisation to Exkivity (mobocertinib) as a monotherapy for adult patients with locally advanced or metastatic non-small cell lung cancer with abnormal epidermal growth factor receptor (EGFR).
The patients involved had disease progression after prior platinum-based chemotherapy
.
The approval marks an important milestone as there have been no previous targeted therapies for this specific type of lung cancer
.
Locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (EGFR Exon20ins) primarily affects young adults and non-smokers and has a worse prognosis than other EGFR mutations
Due to the aggressive nature of the disease, there have been no previous treatments specifically targeting EGFR Exon20ins mutations
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In a phase I/II non-randomized clinical trial, researchers investigated the efficacy and safety of mobocertinib in patients with EGFR exon 20 insertion (EGFRex20ins)-positive metastatic non-small cell lung cancer (mNSCLC) who had previously received platinum-based chemotherapy .
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The results showed that mobocertinib demonstrated antitumor activity in patients with EGFRex20ins-positive mNSCLC, who had an objective response rate of 28%, a median duration of response of 17.
NSCLC results showed that mobocertinib demonstrated antitumor activity in patients with EGFRex20ins-positive mNSCLC, who had an objective response rate of 28%, a median duration of response of 17.
Figure 1.
Efficacy of Mobocertinib in patients with EGFRex20ins mutation-positive metastatic NSCLC
Efficacy of Mobocertinib in patients with EGFRex20ins mutation-positive metastatic NSCLC
Professor Sanjay Popat, Medical Oncologist, NHS Foundation Trust Adviser, explained: "The accelerated approval of mobocertinib is a testament to the promise that this treatment can offer to patients who desperately need a targeted treatment option
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Oral administration also provides the potential for this treatment option.
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