Mobocertinib Withdrawal: EFFECT on Lung Cancer Treatment


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lung cancer treatment MOBOCERTINIB

In recent years, the field of oncology has seen promising advancements in the form of targeted therapies for various cancers. Mobocertinib, a tyrosine kinase inhibitor (TKI), emerged as a beacon of hope for lung cancer patients. However, its journey took an unexpected turn as safety concerns prompted its withdrawal from the market.

EGFR+ lung cancer is a subtype of lung cancer that arises from one or more nonhereditary gene mutations and it is not associated with smoking.

Mobocertinib (Brand Name: EXKIVITY) is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Wang, J., Lam, D., Yang, J., & Hu, L. (2022, September 1). Discovery of mobocertinib, a new irreversible tyrosine kinase inhibitor indicated for the treatment of non-small-cell lung cancer harboring EGFR exon 20 insertion mutations. Medicinal Chemistry Research.

Takeda Provides Update on Lung Cancer Program. (n.d.). Takeda Pharmaceutical Company Limited.

Why Takeda withdrew Mobocertinib from the market?

Takeda, the manufacturer of Mobocertinib, decided to pull the medicine from distribution in the US and later in the UK due to its lack of meaningful impact on progression-free survival in phase 3 clinical trials. Patients who initiated Mobocertinib treatment prior to its discontinuation can continue obtain the medicine at no cost through a compassionate use program.

The EXCLAIM-2 trial was a Phase 3, multicenter, open-label study that aimed to assess the safety and effectiveness of EXKIVITY as a standalone treatment compared to platinum-based chemotherapy in first-line EGFR Exon20 insertion+ locally progressed or metastatic NSCLC. No additional safety concerns were identified in the EXCLAIM-2 trial.

Impact of the Withdrawal

Healthcare professionals and individuals are disappointed and concerned about the removal of Mobocertinib. There are requests for the National Institute for Health and Care Excellence (NICE) to update its recommendations to incorporate additional efficacious medications. The Medicines and Healthcare products Regulatory Agency is allegedly ensuring access to alternate therapies for lung cancer patients after Mobocertinib was withdrawn.

Challenges and Consequences

Experts caution that patients with EGFR lung cancer will have few therapeutic alternatives other from chemotherapy following the discontinuation of Mobocertinib. This may decrease life expectancy and raise mortality. Moreover, the disparity in access via compassionate use programs has also been emphasized. These programs enable certain patients to keep taking Mobocertinib, leading to unequal access to treatment.

What Now?

Ongoing conversations are being held over the timely access to novel cancer medications, including Mobocertinib, and the government’s efforts to guarantee access to treatments for lung cancer. It is crucial to promptly approve and make available alternative and effective treatments. The healthcare community is promoting a fair and just healthcare system that provides all lung cancer patients with access to excellent treatment alternatives.

The removal of Mobocertinib highlights the importance of ongoing research, development, and availability of effective medications in improving the outlook for lung cancer patients. It emphasizes the need of healthcare policies that focus on patients’ needs and guarantee fair access to life-saving therapies.

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