Btobioinnovation.com 

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

SPECIAL REPORT #21.4

Oncology Drug Approvals in 2021

Each year in January, Bruno Pagliara, an oncology specialist, publishes in MedNous, a review where he comments the yearly oncology regulatory approvals. The number of oncology drug approvals in 2021,  in the four following geographic regions: the US, the European Union, China and Japan, reached the impressive number of 94.

The comparison with 2020 is highly indicative of the continuous emergence of China with 25 approvals this year up from zero in 2017.

                                                               2020                                   2021

New Drugs                                               27                                         30

First-in-Class                                             8                                           8

New Indications                                      50                                          64     

Total Approvals                                       77                                          94

US/China approvals                              59/7                                      54/25

The eight regulatory approvals involving first-in-class (none in China) are:

• Anamorelin (Adlumiz), from Ono Pharmaceutical, a small molecule ghrelin receptor agonist for the treatment of cancer cachexia, a metabolic disorder syndrome.
• Amivantamab (Rybrevant) from Johnson & Johnson, a bispecific antibody for the treatment of metastic non-small cell lung cancer.
• Belumosudil (Rezurock) from Kadmon, a small molecule targeting ROCK2, for patients with graft-versus-host disease (GCHD) complications.
• Belzutifan, from Merck & Co, a small molecule inhibitor of the transcription factor HIF-2-alpha, for the treatment of patients with von Hippel-Lindau (VHL) disease.
• Idecabtagene vicleucel (Abcema), a CAR T cell therapy from Bristol Myers Squibb, for the treatment of relapsed or refractory multiple myeloma.
• Loncastuximab tesirine (Zynlonta) from ADC Therapeutics, an antibody-drug conjugate for the treatment of relapsed or refractory large B cell lymphoma.
• Sotorasib (Lumakras) from Amgen, a small molecule KRAD inhibitor for the treatment of metastic non-small cell lung cancer.
• Tisotumab vedotin (Tidvak) from Seagen, an antibody drug conjugate, for patients with metastatic cervical cancer.

64 drugs received a new therapeutic indication, many of them checkpoint inhibitors.

Single-arm studies with objective response rate as the primary enpoint accounted for 23 of the 30 new drugs and 25 out of the 64 new indications.

19 drug applications were not successful after filing : 5 received a complete response letter, 11 which had accelerated procedure status were withdrawn from the market because of failure of confirmatory studies.

As of 2022, 30 new drugs have already been filed within one of the four above mentioned geographic regions of which 10 are being developed by Chinese companies and filed in China.

Full report by Bruno Pagliari in the January 2022 Mednous issue.

Paris, January 25, 2022

This document has been prepared by btobioinnovation and is provided to you for information purposes only.  The information contained in this document has been obtained from sources that btobioinnovation believes are reliable but btobioinnovation does not warrant that it is accurate or complete. The views presented in this document are those of btobioinnovation’s editor at the time of writing and are subject to change.  btobioinnovation has no obligation to update its opinions or the information in this document.