An Update on Mobocertinib

This month, we were very sad to see Mobocertinib withdrawn from the market by Takeda on March 8th. Mobocertinib was the only targeted drug licensed for use with NHS patients with EGFR+ Exon 20 mutations.

The current situation (and why it is so frustrating)

Mobocertinib was not withdrawn due to safety concerns; instead, it was withdrawn because it was licensed on the proviso that it was shown to be more effective than chemotherapy in a randomised controlled trial (RCT). Unfortunately, this RCT (EXCLAIM-2) failed to demonstrate this ‘superiority effect’. However, it did find the drug to be as effective as chemotherapy in a first line setting. Given these findings, EGFR+ UK have spent much of the first quarter of this year campaigning for the withdrawal of Mobocertinib to be reconsidered. To this end, we managed to get this issue covered in a number of media outlets, and even debated in the House of Lords on February 14th. Unfortunately though, the drug was still withdrawn from the global market, creating an unprecedented situation and leaving a significant unmet need for Exon 20 patients in the UK.

So, what now?

We are currently working with Takeda to ensure any Exon 20 patients who are currently taking Mobocertinib will continue to receive the drug, for as long as it is effective. For those who have yet to be prescribed it, we are continuing to campaign for better drug access in the UK. For example, while there are no alternative drugs currently available on the NHS, there is an Exon 20 drug that has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the UK: Amivantamab.

Amivantamab has been the subject of a number of clinical trials this year, and its effectiveness has been repeatedly demonstrated in these studies. While Amivantamab is not currently NICE approved (and therefore not currently available on the NHS), we do expect this to change in the future. But in the meantime, we need an alternative. To this end, we are doing everything we can to make this happen. We are actively petitioning NICE, NHS England and Government officials to find a way to get Exon 20 patients access to Amivantamab, while we wait for approval. We are working with Exon 20 patients and lung cancer specialists to get our voice heard. And we are working closely with Janssen (the pharmaceutical company that produces it) to find ways of potentially facilitating access to Amivantamab for those who need it.

What about trials?

There are a number of international pharmaceutical companies who are currently creating and testing new Exon 20 drugs. EGFR+ UK is working with these companies in the hope that we can help to bring their clinical trials over to the UK, and make these drugs available to Exon 20 patients in this country. We will keep you posted on this, and let you know as and when these trials become live.