Oncology Drug Approvals in 2021
Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation firstname.lastname@example.org
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.
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not successful after filing : 5 received a complete response letter, 11 which had accelerated procedure status were withdrawn from the market because of failure of confirmatory studies.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
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