New Treatment Options In Oncology: FDA And EMA Drug Approvals In Q4 2022

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There was 1 product indication withdrawn in the US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
Generic Name	Brand Name	Tumor Type^a	MOA	Manufacturer	Approval
Durvalumab^b + tremelimumab-actl	Imfinzi + Imjudo	Hepatocellular carcinoma	PD-L1 blocker	AstraZeneca	10/12/22 (FDA) and December 2022 (EMA)
Durvalumab^b + tremelimumab-actl	Imfinzi + Imjudo	NSCLC	PD-L1 blocker	AstraZeneca	11/10/22 (FDA) and December 2022 (EMA)

FDA Approvals
Generic Name	Brand Name	Tumor Type^a	MOA	Manufacturer	Approval
Adagrasib	Krazati	NSCLC	KRAS G12C inhibitor	Genentech	12/12/22^c
Atezolizumab^b	Tecentriq	Alveolar soft part sarcoma	PD-1/PD-L1 inhibitor	Genentech	12/09/22
Brentuximab vedotin^a	Adcetris	Pediatric Hodgkin lymphoma	CD30-directed ADC	Seagen	11/10/22
Cemiplimab^a	Libtayo	Cervical cancer	PD-1 inhibitor	Regeneron	11/08/22
Cobimetinib	Cotellic	Histiocytic neoplasms	MAPK/MEK1/ MEK2 inhibitor	Genentech	10/28/22
Mirvetuximab soravtansine-gynx^b	Elahere	Epithelial ovarian, fallopian tube, or primary peritoneal cancer	Folate receptor alpha (FR⍺)-directed antibody and microtubule inhibitor conjugate	ImmunoGen	11/14/22^c
Mosunetuzumab-axgb^b	Lunsumio	Follicular lymphoma	Bispecific CD20-directed CD3 T-cell engager	Genentech	12/23/22^c
Nadofaragene firadenovec-vncg^b	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-cqyv^b	Tecvayli	Relapsed/refractory multiple myeloma	T-cell–redirecting bispecific antibody	Janssen Biotech	10/25/22

EMA Approvals
Generic Name	Brand Name	Tumor Type^a	MOA	Manufacturer	Approval
Cemiplimab^a	Libtayo	Cervical cancer	PD-1 inhibitor	Regeneron	October 2022
Durvalumab^b	Imfinzi	Biliary tract cancer	PD-L1 blocker	AstraZeneca	November 2022
Lutetium (¹⁷⁷Lu) vipivotide tetraxetan	Pluvicto	Prostate cancer	Therapeutic radiopharmaceutical	Novartis	October 2022^d
Olaparib^b	Lynparza	Prostate cancer	PARP inhibitor	AstraZeneca	November 2022
Pemetrexed	Pemetrexed (generic)	Malignant pleural mesothelioma and NSCLC	Folate analog metabolic inhibitor	Baxter Holding	October 2022^d
Pemetrexed	Pemetrexed (generic)	Malignant pleural mesothelioma and NSCLC	Folate analog metabolic inhibitor	Baxter Holding	October 2022^d
Plerixafor	Plerixafor (generic)	Lymphoma and multiple myeloma	CXCR4 inhibitor	Accord Healthcare	October 2022^d
Trastuzumab deruxtecan^b	Enhertu	HER2+ gastric cancer GEJ adenocarcinoma	HER2-directed ADC	Daiichi Sankyo Europe	November 2022
Zanubrutinib^b	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.

Categories

Archives

FDA and EMA Approvals

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

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

Tumor Type^a

Durvalumab^b + tremelimumab-actl

Durvalumab^b + tremelimumab-actl

Tumor Type^a

12/12/22^c

Atezolizumab^b

Brentuximab vedotin^a

Cemiplimab^a

Mirvetuximab soravtansine-gynx^b

11/14/22^c

Mosunetuzumab-axgb^b

12/23/22^c

Nadofaragene firadenovec-vncg^b

Teclistamab-cqyv^b

Tumor Type^a

Cemiplimab^a

Durvalumab^b

Lutetium (¹⁷⁷Lu) vipivotide tetraxetan

October 2022^d

Olaparib^b