Buffalo: A new pill for a rare form of lung cancer has shown strong results in early trials and is now available to patients after fast-track approval by the US Food and Drug Administration.
Published in Cancer Discovery in January 2026, early trial results for sevabertinib show that the drug can shrink tumours in a majority of patients with HER2 exon 20, a mutated lung cancer found in roughly 2-3 per cent of cases.
For years, this small number meant less research attention and fewer tailored drugs. Most patients in this group have had to rely on chemotherapy or immunotherapy, treatments that are broader, often harsher, and not always effective.
Sevabertinib, sold under the brand name Hyrnuo, is part of a growing class of “precision medicines”—drugs designed to target specific genetic changes that drive cancer growth. It was developed through a collaboration between Bayer, a German pharmaceutical company, and researchers at the Dana-Farber Cancer Institute and the Broad Institute in Boston.
The drug works by blocking a mutated form of the HER2 protein, which sends constant signals for cancer cells to grow. By shutting down this signal, sevabertinib can slow or shrink tumours, the study shows. Many patients in trials experienced months where the disease stopped progressing.
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Not replacing existing treatments
In sevabertinib’s global SOHO-01 phase I/II trial, around 70 per cent of patients experienced tumour shrinkage, an improvement over earlier therapies, which showed response rates closer to 50 per cent in similar settings.
The drug is currently approved for patients who have already gone through systemic therapy such as chemotherapy and immunotherapy. Ongoing studies may expand its use earlier in the treatment timeline.
Unlike infusion-based therapies, sevabertinib is a pill that can be taken at home. For patients already dealing with advanced cancer, that means fewer hospital visits.
Doctors also point to another advantage: flexibility. Because the drug’s effects are reversible, treatment can be paused or adjusted if side effects become difficult, something not always possible with older therapies.
Common side effects patients complained of during trials include diarrhoea, rash, nausea, and mouth sores. More serious complications can include lung inflammation, liver damage and eye problems. The drug is also not entirely safe for pregnant patients and needs constant monitoring.
Sevabertinib is not replacing existing treatments. Researchers are now exploring combinations like pairing mutation-specific drugs with other targeted or immune therapies.
Sevabertinib shows precision medicine working: one pill for one mutation. But challenges remain about how to completely remove the tumours from the patients with almost negligible chance of relapse.
Arun Singh is an alumna of TPSJ.
(Edited by Saptak Datta)