The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved more than 30 new oncology agents and new indications for previously approved agents during the fourth quarter of 2022. The majority of these approvals were for new—or new indications for—biologics, with more than 11 different biologics and biosimilars receiving at least 1 approval. One of the main highlights was the approval of durvalumab + tremelimumab (Imfinzi® + Imjudo®; AstraZeneca) by both agencies. Durvalumab + tremelimumab is a biologic combination therapy approved for patients with liver or non-small cell lung cancers (NSCLC).
Additional highlights from the last quarter of 2022 include
- Adagrasib (Krazati®; Genentech), a RAS GTPase family inhibitor, received accelerated approval by the FDA for treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least 1 prior systemic therapy
- Companion diagnostics were also approved: the QIAGEN therascreen® KRAS RGQ PCR kit (tissue) and the Agilent Resolution ctDx FIRST assay (plasma)
- Teclistamab-cqyv (Tecvayli®; Janssen Biotech), a T-cell–redirecting bispecific antibody, received orphan status for treatment of relapsed/refractory multiple myeloma
- New indications were approved for several previously approved therapies
- Cemiplimab (Libtayo®; Regeneron) by the EMA for recurrent or metastatic cervical cancer; by the FDA for first-line treatment of NSCLC
- Cobimetinib (Cotellic®; Genentech) by the FDA for histiocytic neoplasms
- Durvalumab (Imfinzi®; AstraZeneca) by the EMA for biliary tract cancer
- Olaparib (Lynparza®; AstraZeneca) by the EMA in combination with abiraterone and prednisone or prednisolone for metastatic castration-resistant prostate cancer
- Trastuzumab deruxtecan (Enhertu®; Daiichi Sankyo Europe) received 2 EMA approvals, for human epidermal growth factor receptor 2-positive (HER2+) gastric cancer or gastroesophageal junction adenocarcinoma and for HER2-low metastatic breast cancer
- Zanubrutinib (Brukinsa®; BeiGene Ireland) by the EMA for chronic lymphocytic leukemia
- There were 5 new indications for pemetrexed: 3 for the formulation manufactured by Actavis, 1 new indication for Eagle Pharmaceuticals (Pemfexy®) by the FDA, and a positive opinion by the EMA for the formulation manufactured by Baxter Holding
- There was 1 product indication withdrawn in the US
- The urothelial carcinoma accelerated approval for atezolizumab (Tecentriq®; Genentech) was withdrawn by the FDA in December
- 2 new diagnostics were approved, for prostate and lung cancer diagnoses
- A diagnostic radiopharmaceutical, gozetotide (Locametz®; Novartis), received positive opinion from the EMA in October for diagnosis of prostate cancer
- Pafolacianine sodium (Cytalux®; On Target Laboratories) was approved by the FDA for identification of pulmonary lesions in patients with known or suspected lung cancer
- Under its Project Renewal initiative, the FDA approved several new and updated indications for capecitabine (Xeloda®; Genentech)
The tables below summarize key Q4 oncology approvals:
FDA and EMA Approvals |
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Generic Name |
Brand Name |
Tumor Typea |
MOA |
Manufacturer |
Approval |
Durvalumabb + tremelimumab-actl |
Imfinzi + Imjudo |
Hepatocellular carcinoma |
PD-L1 blocker |
AstraZeneca |
10/12/22 (FDA) and December 2022 (EMA) |
Durvalumabb + tremelimumab-actl |
Imfinzi + Imjudo |
NSCLC |
PD-L1 blocker |
AstraZeneca |
11/10/22 (FDA) and December 2022 (EMA) |
FDA Approvals |
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Generic Name |
Brand Name |
Tumor Typea |
MOA |
Manufacturer |
Approval |
Adagrasib |
Krazati |
NSCLC |
KRAS G12C inhibitor |
Genentech |
12/12/22c |
Atezolizumabb |
Tecentriq |
Alveolar soft part sarcoma |
PD-1/PD-L1 inhibitor |
Genentech |
12/09/22 |
Brentuximab vedotina |
Adcetris |
Pediatric Hodgkin lymphoma |
CD30-directed ADC |
Seagen |
11/10/22 |
Cemiplimaba |
Libtayo |
Cervical cancer |
PD-1 inhibitor |
Regeneron |
11/08/22 |
Cobimetinib |
Cotellic |
Histiocytic neoplasms |
MAPK/MEK1/ MEK2 inhibitor |
Genentech |
10/28/22 |
Mirvetuximab soravtansine-gynxb |
Elahere |
Epithelial ovarian, fallopian tube, or primary peritoneal cancer |
Folate receptor alpha (FR⍺)-directed antibody and microtubule inhibitor conjugate |
ImmunoGen |
11/14/22c |
Mosunetuzumab-axgbb |
Lunsumio |
Follicular lymphoma |
Bispecific CD20-directed CD3 T-cell engager |
Genentech |
12/23/22c |
Nadofaragene firadenovec-vncgb |
Adstiladrin |
Bladder cancer |
Gene therapy |
Ferring Pharmaceuticals |
12/16/22 |
Olutasidenib |
Rezlidhia |
AML |
IDH1 inhibitor |
Forma Therapeutics |
12/1/22 |
Pegfilgrastim-cbqv (biosimilar) |
Udenyca |
Patients acutely exposed to myelosuppressive doses of radiation |
G-CSF |
Coherus BioSciences |
11/28/22 |
Pemetrexed |
Pemetrexed (generic) |
Metastatic non-squamous NSCLC (in combination with pembrolizumab and platinum chemotherapy) |
Folate analog metabolic inhibitor |
Actavis |
11/22/22 |
Pemetrexed |
Pemetrexed (generic) |
Malignant pleural mesothelioma (in combination with cisplatin) |
Folate analog metabolic inhibitor |
Actavis |
11/22/22 |
Pemetrexed |
Pemetrexed (generic) |
Malignant pleural mesothelioma (in combination with cisplatin) |
Folate analog metabolic inhibitor |
Actavis |
11/22/22 |
Pemetrexed |
Pemfexy |
Metastatic non-squamous NSCLC (in combination with pembrolizumab and platinum chemotherapy) |
Folate analog metabolic inhibitor |
Eagle Pharmaceuticals |
12/14/22 |
Teclistamab-cqyvb |
Tecvayli |
Relapsed/refractory multiple myeloma |
T-cell–redirecting bispecific antibody |
Janssen Biotech |
10/25/22 |
EMA Approvals |
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Generic Name |
Brand Name |
Tumor Typea |
MOA |
Manufacturer |
Approval |
Cemiplimaba |
Libtayo |
Cervical cancer |
PD-1 inhibitor |
Regeneron |
October 2022 |
Durvalumabb |
Imfinzi |
Biliary tract cancer |
PD-L1 blocker |
AstraZeneca |
November 2022 |
Lutetium (177Lu) vipivotide tetraxetan |
Pluvicto |
Prostate cancer |
Therapeutic radiopharmaceutical |
Novartis |
October 2022d |
Olaparibb |
Lynparza |
Prostate cancer |
PARP inhibitor |
AstraZeneca |
November 2022 |
Pemetrexed |
Pemetrexed (generic) |
Malignant pleural mesothelioma and NSCLC |
Folate analog metabolic inhibitor |
Baxter Holding |
October 2022d |
Pemetrexed |
Pemetrexed (generic) |
Malignant pleural mesothelioma and NSCLC |
Folate analog metabolic inhibitor |
Baxter Holding |
October 2022d |
Plerixafor |
Plerixafor (generic) |
Lymphoma and multiple myeloma |
CXCR4 inhibitor |
Accord Healthcare |
October 2022d |
Trastuzumab deruxtecanb |
Enhertu |
HER2+ gastric cancer GEJ adenocarcinoma |
HER2-directed ADC |
Daiichi Sankyo Europe |
November 2022 |
Zanubrutinibb |
Brukinsa |
Chronic lymphocytic leukemia |
BTK inhibitor |
BeiGene Ireland |
October 2022 |
aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information.bBiologic.cAccelerated approval.dPositive opinion.ADC, antibody-drug conjugate; AML, acute myeloid leukemia; BTK, Bruton tyrosine kinase; CXCR4, C-X-C motif chemokine receptor 4; EMA, European Medicines Agency; FDA, US Food and Drug Administration; G-CSF, granulocyte colony-stimulating factor; GEJ, gastroesophageal junction; GTP, guanosine triphosphate; HER2+, human epidermal growth factor receptor 2 positive; IDH1, isocitrate dehydrogenase 1; KRAS, Kirsten rat sarcoma viral oncogene; MAPK, mitogen-activated protein kinase; MOA, mechanism of action; NSCLC, non-small cell lung cancer; PARP, poly(ADP-ribose) polymerase; PCR, polymerase chain reaction; PD-1, programmed cell death protein 1; PD-L1, PD-1 ligand 1; RAS, rat sarcoma viral oncogene; RGQ, Rotor-Gene Q. |
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