Bayer is hoping sevabertinib will be the next alectinib

April 8th 2026

Last November, Bayer’s accelerated approval by the FDA for sevabertinib in refractory metastatic HER2 positive non-squamous cell lung cancer was based around the belief that developing targeted drugs for a tiny cohort of patients in a very common malignancy was a “relatively” more straightforward path to getting drug approvals and outsized returns. And that bet has worked out well so far.

Now it sets its sight on proving that sevabertinib is better that current treatment options in the first line lung cancer setting, hoping to mirror the success of alectinib; currently generating $1.6 billion dollars for Roche in ALK positive lung cancer. HER2 positive lung cancer like ALK positive lung cancer represents 2-4% of the lung cancer population.

A valuation of sevabertinib done by PharmaCalc suggests that sevabertinib could represent a similar commercial valuation if it’s able to succeed in the ongoing phase three trial. Modeling shows sevabertinib has an expected net present value of $1.55 billion and a commercial value of $2.8 billion if successful in the pivotal phase three trial and an excellent investment for Bayer with an investment efficiency of 70.

Gaining an accelerated approval in the second line setting based on a single arm trial follows a tried and trusted pathway for cancer drug approvals but Bayer knows the bigger market lies in the first line metastatic setting which represents the largest patient segment for the most commonly diagnosed malignancy worldwide.