There were several approvals of new oncology agents and new indications during the final months of 2021 by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). One of the main highlights is that immunotherapy, particularly checkpoint inhibitor therapy, continues to expand, with multiple new approvals in the fourth quarter. Programmed cell death protein 1 ligand 1 (PD-L1) inhibitor pembrolizumab (Keytruda®) received EMA approval for treatment of triple-negative breast cancer, renal cell carcinoma, and in combination with lenvatinib (Lenvima® [US]/Kisplyx® [EU]) for treatment of renal cell carcinoma and endometrial carcinoma. Pembrolizumab also received FDA approval in 4 new indications, including use as single-agent or combination therapy for patients with recurrent or metastatic cervical cancer, pediatric melanoma, and renal cell carcinoma. Another PD-L1 inhibitor, atezolizumab (Tecentriq®), received FDA approval for treatment of non-small cell lung cancer in October.
Additional points of interest include
- Six new treatments were approved for non-small cell lung cancer: amivantamab (Rybrevant®; FDA approval), atezolizumab (Tecentriq; FDA approval), lorlatinib (Lorviqua®; EMA approval), pralsetinib (Gavreto®; EMA approval), sotorasib (Lumykras®; EMA approval), and tepotinib (Tepmetko®; EMA approval)
- Several of the new approvals are treatments for hematologic malignancies: brexucabtagene autoleucel (Tecartus®; acute lymphoblastic leukemia), asciminib (Scemblix®; chronic myeloid leukemia), rituximab (Rituxan®; pediatric lymphomas), and daratumumab + hyaluronidase-fihj and carfilzomib + dexamethasone (Darzalex Faspro® + Kyprolis® + dexamethasone; multiple myeloma)
- Three new treatments were approved for breast cancer: abemaciclib (Verzenio®; FDA approval), pembrolizumab (Keytruda®; EMA approval for triple-negative breast cancer), and sacituzumab govitecan (Trodelvy®; EMA positive opinion for triple-negative breast cancer)
- A bevacizumab biosimilar, Mvasi®, was approved by the FDA for ovarian, fallopian tube, or primary peritoneal cancers
- Many newly approved products (eg, atezolizumab, abemaciclib, lorlatinib, pralsetinib, sotorasib, tepotinib) target specific genetic mutations, leading to simultaneous approvals of accompanying diagnostics. For example, the Ventana PD-L1 Assay was approved as a companion diagnostic device with atezolizumab
- A new diagnostic imaging agent, Cytalux™ , was approved for identifying ovarian cancers
The tables below summarize key Q4 approvals:
FDA and EMA Approvals |
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Generic Name |
Brand Name |
Tumor Typea |
MOA |
Manu-facturer |
Approval |
Pembrolizumab |
Keytruda |
Renal cell carcinoma |
PD-L1 inhibitor |
Merck |
November (FDA) and December 2021 (EMA) |
MOA, mechanism of action.aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information.
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FDA Approvals |
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Generic Name |
Brand Name |
Tumor Typea |
MOA |
Manu-facturer |
Approval |
Abemaciclib |
Verzenio |
Breast cancer |
CDK4/6 inhibitor |
Eli Lilly and Company |
October 2021 |
Asciminib |
Scemblix |
Chronic myeloid leukemia |
STAMP inhibitor |
Novartis AG |
October 2021 |
Atezolizumab |
Tecentriq |
Non-small cell lung cancer |
PD-L1 inhibitor |
Genentech, Inc |
October 2021 |
Bevacizumab |
Mvasi |
Ovarian, fallopian tube, or primary peritoneal cancer |
(Biosimilar) |
Amgen, Inc |
November 2021 |
Brexucabtagene autoleucel |
Tecartus |
Acute lymphoblastic leukemia |
CAR T-cell therapy |
Kite Pharma, Inc |
October 2021 |
Daratumumab + hyaluronidase-fihj and carfilzomib + dexamethasone |
Darzalex Faspro + Kyprolis + dexamethasone |
Multiple myeloma |
Janssen Biotech, Inc and Amgen, Inc |
November 2021 |
|
Pafolacianine |
Cytalux™ |
Ovarian |
Optical imaging agent |
On Target Laboratories |
November 2021 |
Pembrolizumab |
Keytruda |
Cervical cancer |
PD-L1 inhibitor |
Merck |
October 2021 |
Pembrolizumab |
Keytruda |
Melanoma |
PD-L1 inhibitor |
Merck |
December 2021 |
Rituximab + chemotherapy |
Rituxan |
Pediatric lymphoma |
Monoclonal antibody |
Genentech, Inc |
December 2021 |
Sirolimus protein-bound particles for injectable suspension |
Fyarro™ |
Perivascular epithelioid cell tumor |
mTOR inhibitor |
Aadi Bioscience, Inc |
November 2021 |
CAR, chimeric antigen receptor; CDK4/6, cyclin-dependent kinase 4/6; mTOR, mechanistic target of rapamycin; STAMP, specifically targeting the ABL myristoyl pocket.aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information. |
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EMA Approvals |
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Generic Name |
Brand Name |
Indication |
MOA |
Manu-facturer |
Approval |
Amivantamab |
Rybrevant |
Non-small cell lung cancer |
Fully human, bispecific antibody |
Janssen-Cilag International N.V. |
Conditional marketing authorization October 2021 |
Enfortumab vedotin |
Padcev® |
Urothelial cancer |
Antibody-drug conjugate |
Astellas Pharma Europe B.V. |
Positive opinion December 2021 |
Lorlatinib |
Lorviqua |
Non-small cell lung cancer |
ALK and ROS1 inhibitor |
Pfizer |
Positive opinion December 2021 |
Pembrolizumab |
Keytruda |
Triple-negative breast cancer |
PD-L1 inhibitor |
Merck |
October 2021 |
Pembrolizumab + lenvatinib |
Keytruda + Kisplyx |
Renal cell carcinoma and endometrial carcinoma |
PD-L1 inhibitor + TKI |
Merck and Eisai |
Positive opinion October 2021 |
Pralsetinib |
Gavreto |
Non-small cell lung cancer |
RET inhibitor |
Roche |
Conditional marketing approval November 2021 |
Sacituzumab govitecan |
Trodelvy |
Triple-negative breast cancer |
Trop-2–directed antibody and topoisomerase inhibitor conjugate |
Gilead |
Positive opinion October 2021 |
Sotorasib |
Lumykras (EU) |
Non-small cell lung cancer |
KRASG12C inhibitor |
Amgen |
Positive opinion November 2021 |
Tegafur/gimeracil/oteracil |
Teysuno® |
Colorectal cancer |
Antimetabolite |
Nordic Group |
Positive opinion December 2021 |
Tepotinib |
Tepmetko |
Non-small cell lung cancer |
MET inhibitor |
Merck |
Positive opinion December 2021 |
ALK, anaplastic lymphoma kinase; TKI, tyrosine kinase inhibitor. |
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Sources:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process
