There is a new cancer drug on the market. Alectinib just received its first regulatory approval for non-small cell lung cancer. It was approved in Japan for a subset of such cancers, those that are known as ALK+ (anaplastic lymphoma kinase fusion gene-positive).
It’s interesting to me that this is a drug originally discovered by a Japanese company, Chugai Pharmaceutical (which is a subsidiary of Roche) and Japan is where its first approval was obtained. I’ve seen this pattern before, where drugs discovered in a smaller country are first approved in that country. It makes we wonder why that is the case. The United States and Europe are the largest pharmaceutical markets and they are usually where approval is first sought and obtained – smaller markets generally follow later.
I think it points to the subjective nature of regulatory approval. Perhaps it is because of national pride. Regulators may be pleased to see a “home-grown” drug and are therefore more favorably disposed towards it. Or maybe there are influences from some form of regulatory capture, where the institutions that are doing the regulation draw their employees from the industry that is being regulated, introducing a bias. Or maybe the company that developed the drug is just more familiar with the regulatory approval process in their own country than in other jurisdictions.
Regardless of the how it makes it to the market, it’s good to see another weapon in the arsenal for treating cancer. Additional clinical trials are underway, and hopefully they will find that the drug will be able to benefit a broader range of cancer patients.