In the second quarter of 2023, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved more than 21 new oncology agents and new indications for previously approved agents. The cancer types with the most approvals were diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma and non-small cell lung cancer (NSCLC). There were 5 diagnostic agents, 8 biologics, 3 programmed cell death protein 1 inhibitors, and 4 antibody-drug conjugates approved. One treatment, glofitamab-gxbm (Columvi™; Genentech/Roche), was approved by both the FDA and the EMA for treatment of DLBCL.
Additional highlights from the second quarter of 2023 include
- 2 previous accelerated approval products received full approval by the FDA: blinatumomab (Blincyto®; Amgen) for adult and pediatric B-lymphocyte antigen CD19-positive B-cell precursor acute lymphoblastic leukemia; and polatuzumab vedotin-piiq (Polivy®; Genentech) with bendamustine and a rituximab product for relapsed/refractory DLBCL, not otherwise specified (NOS)
- 3 product indications were expanded with new approvals by the EMA
- Nivolumab (Opdivo®; Bristol-Myers Squibb) melanoma indications were expanded to include pediatric patients aged 12 and older
- Ipilimumab (Yervoy®; Bristol-Myers Squibb) expanded from monotherapy indication to approval for use in combination with nivolumab for treatment of melanoma
- Sacituzumab govitecan (Trodelvy®; Gilead Sciences Ireland) for unresectable or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer, in addition to its previous indication for triple-negative breast cancer
- 4 new diagnostics were approved by the FDA
- Flotufolastat F 18 (Posluma®; Blue Earth Diagnostics), a radioactive diagnostic agent approved by the FDA for positron emission tomography of prostate-specific membrane antigen-positive lesions in men with prostate cancer
- Indocyanine green for injection (Spy Agent® Green; Novadaq Tech) for visualization of lymph nodes and lymphatic vessels during lymphatic mapping in adults with breast cancer
- Iopromide (Ultravist® [-300, -370]; Bayer) for contrast-enhanced mammography
- FoundationOne® Liquid CDx (Foundation Medicine), for diagnosing metastatic colorectal cancer with B-Raf proto-oncogene V600E alteration as a companion diagnostic for encorafenib (Braftovi®; Pfizer)
- 1 new diagnostic was approved by the EMA: piflufolastat (18F) (Pylclari®; Curium Pet France) for prostate cancer diagnosis
- Under its Project Orbis initiative, the FDA granted accelerated approval for glofitamab-gxbm (Columvi™; Genentech) to treat relapsed or refractory DLBCL, NOS or large B-cell lymphoma arising from follicular lymphoma, in collaboration with Switzerland’s Swissmedic
- 2 indications for ibrutinib (Imbruvica®; Pharmacyclics) were removed by the FDA
- Mantle cell lymphoma after at least 1 prior therapy
- Marginal zone lymphoma after at least 1 prior anti–B-lymphocyte antigen CD20–based therapy
- The EMA application for ivosidenib (Tidhesco®; Les Laboratoires Servier) in acute myeloid leukemia was withdrawn after receiving positive opinion in February 2023, because the application was a duplicate of Tibsovo® (Les Laboratoires Servier)
- The pralsetinib (Gavreto®; Genentech) indication for Ret proto-oncogene–mutant medullary thyroid cancer was also removed by the FDA (pralsetinib had previously received prior approval)
The tables below summarize key Q2 2023 oncology approvals:
FDA Approvals |
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Generic Name |
Brand Name |
Tumor Typea |
MOA |
Manufacturer |
Approval |
Blinatumomab |
Blincyto |
ALL |
CD19-directed CD3 T-cell engager |
Amgen |
6/20/23 |
Enfortumab vedotin-ejfv + pembrolizumab |
Padcev |
Urothelial carcinoma |
Nectin-4–directed ADC |
Astellas Pharma |
4/03/23 |
Epcoritamab-byspb |
Epkinly |
DLBCL, HGBCL |
Bispecific CD20-directed CD3 T-cell engager |
Genmab US |
5/19/23 |
Flotufolastat F 18 |
Posluma |
Prostate cancer (diagnostic) |
Radioactive diagnostic agent |
Blue Earth Diagnostics |
5/25/23 |
Glofitamab-gxbmb |
Columvi |
DLBCL, NOS or LBCL arising from FL |
T-cell–engaging bispecific antibody |
Genentech |
6/15/23c |
Indocyanine green |
Spy Agent Green |
Breast cancer (diagnostic) |
Diagnostic agent |
Novadaq Tech |
6/05/23 |
Iopromide |
Ultravist (-300, -370) |
Breast cancer (diagnostic) |
Iodine-based contrast agent |
Bayer |
5/25/23 |
Niraparib |
Zejula |
Epithelial ovarian, fallopian tube, primary peritoneal (advanced and BRCA-mutated indications) |
PARP inhibitor |
GlaxoSmithKline |
4/26/23 |
Olaparib |
Lynparza |
BRCA-mutated CRPC |
PARP inhibitor |
AstraZeneca |
5/31/23 |
Omidubicelb |
Omisirge |
Hematologic malignancies |
Cryopreserved nicotinamide-modified allogeneic hematopoietic progenitor cell therapy |
Gamida Cell |
4/17/23 |
Pembrolizumabb |
Keytruda |
Urothelial carcinoma |
PD-1 inhibitor |
Merck |
4/03/23 |
Pemetrexed |
Pemetrexed injection |
NSCLC |
Antifolate |
Shilpa Medicare |
5/22/23 |
Polatuzumab vedotin-piiqb |
Polivy |
(with R-CHP) DLBCL, NOS and HGBCL |
CD79b-directed ADC |
Genentech |
4/19/23 |
Polatuzumab vedotin-piiqb |
Polivy |
(with bendamustine and a rituximab product) DLBCL, NOS and HGBCL |
CD79b-directed ADC |
Genentech |
4/19/23 |
Polyethylene glycol 3350; sodium sulfate; potassium chloride; magnesium sulfate; sodium chloride) |
Suflave |
Cleansing of the colon |
Colonoscopy prep |
Braintree Labs |
6/15/23 |
Talazoparib |
Talzenna |
Metastatic CRPC |
PARP inhibitor |
Pfizer |
6/20/23 |
FoundationOne Liquid CDx |
CRC (diagnostic) |
Diagnostic agent |
Foundation Medicine |
6/9/23 |
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EMA Approvals |
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Generic Name |
Brand Name |
Tumor Typea |
MOA |
Manufacturer |
Approval |
Futibatinib |
Lytgobi |
Cholangiocarcinoma |
FGFR inhibitor |
Taiho Pharma |
April 2023d |
Glofitamab-gxbmb |
Columvi |
DLBCL, NOS or LBCL arising from FL |
T-cell–engaging bispecific antibody |
Roche |
April 2023d |
Ivosidenib |
Tibsovo |
AML and cholangiocarcinoma |
IDH1 inhibitor |
Les Laboratoires Servier |
May 2023 |
Nivolumab |
Opdivo |
Melanoma (pediatric) |
PD-1 inhibitor |
Bristol-Myers Squibb |
April 2023 |
Nivolumab |
Opdivo |
NSCLC (neoadjuvant) |
PD-1 inhibitor |
Bristol-Myers Squibb |
May 2023d |
Piflufolastat (18F) |
Pylclari |
Prostate cancer (diagnostic) |
Diagnostic radiopharmaceutical |
Curium Pet France |
May 2023 |
Pirtobrutinib |
Jaypirca |
MCL |
TBK inhibitor |
Eli Lilly |
April 2023d |
Sacituzumab govitecan-hziyb |
Trodelvy |
Breast cancer |
ADC |
Gilead Sciences, Ireland |
June 2023d |
Tremelimumab-actl |
Imjudo |
NSCLC |
Anti–CTLA-4 antibody |
AstraZeneca |
June 2023d |
Trifluridine/tipiracil |
Lonsurf |
CRC |
Thymidine-based nucleoside analog and thymidine phosphorylase inhibitor |
Les Laboratoires Servier |
June 2023d |
Ipilimumab |
Yervoy |
(In combination with nivolumab) melanoma |
CTLA-4 immune checkpoint inhibitor |
Bristol-Myers Squibb |
April 2023 |
ADC, antibody-drug conjugate; ALL, acute lymphocytic leukemia; AML, acute myeloid leukemia; BRCA, breast cancer gene; CD19, B-lymphocyte antigen CD19; CD20, B-lymphocyte antigen CD20; CD70B, cluster of differentiation 79B; CRC, colorectal cancer; CRPC, castration-resistant prostate cancer; CTLA-4, cytotoxic T-lymphocyte-associated protein 4; DLBCL, diffuse large B-cell lymphoma; EMA, European Medicines Agency; FDA, US Food and Drug Administration; FGFR, fibroblast growth factor receptor; FL, follicular lymphoma; HGBCL, high-grade B-cell lymphoma; IDH1, isocitrate dehydrogenase 1; LBCL, large B-cell lymphoma; MCL, mantle cell lymphoma; MOA, mechanism of action; NOS, not otherwise specified; NSCLC, non-small cell lung cancer; PARP, poly(ADP-ribose) polymerase; PD-1, programmed cell death protein 1; PET, positron emission tomography; R-CHP, rituximab, cyclophosphamide, doxorubicin, and prednisone; TBK, TANK-binding kinase.aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information.bBiologic.cAccelerated approval.dPositive opinion.
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Sources:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process
https://www.ema.europa.eu/en/committees/chmp/chmp-agendas-minutes-highlights
