Btobioinnovation.com

Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #21.6

Oncology 2020 Update

Most of the last reports we issued were focusing on the COVID-19 overall situation. In spite of the coronavirus pandemic, recent progress in the oncology area has also been impressive. In a recent article in the January issue of MedNous (www.mednous.com) Bruno Pagliara provides a thorough and comprehensive analysis of oncology drug approvals in 2020. This report summarises the most striking figures to be found in Pagliara’s article.

Last year there were 26 new oncology approvals, a figure to be compared with 16 new approvals in 2019 and 20 in 2018. These new approved drugs have been granted to 26 different companies. The U.S. FDA has granted first approvals to 8 of them, Japan 4 China 3, the U.K. one. One of the remarkable trend illustrated in the study are the new modes of action supported by 9 of the new drugs in rare as well as common cancers. Remarkably 3 of the drugs with a new mechanism of action received their first regulatory approvals in Japan. Last year saw the approval of drugs for new tumours types. These cancers include: epithelioid sarcoma, primary CNS lymphoma, neurofibromastosis and upper tract urothelial cancer. It is also noteworthy to see that Morphosys AG, a German biotechnology company based in Planegg near Münich, received approval for its first wholly-owned drug from the U.S. FDA.

Approval of new indications of drugs reached the high number of 48, most of them by the U.S. FDA. At the end of 2020, the checkpoint inhibitor group includes 11 different drugs with 83 new indications across 19 tumour types. Merck’s Keytruda, the leading drug of this class, has already been approved for 30 different indications, including the most recent one in triple negative breast cancer.

As stated on several instances, the U.S. FDA remains the preferred regulator for most sponsors active in the oncology area, mainly because the accelerated approval process allows faster market access, provided the companies agree to submit additional clinical data at a later time. The MedNous article states : “During 2020, this type of dossier was used 19 out of 26 new drug applications and for 17 out of 48 applications for new indications”.

“What does this tell us” questions Pagliara? “At the very least it is evidence that innovation is alive and well in the oncology drug sector”.

Paris, February 16, 2021

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