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There was 1 product indication withdrawn in the US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.

Sources:

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process

https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications?t=308050

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-10-13-october-2022

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-7-10-november-2022

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-december-2022

Matthew Gordon

VP, Real-World Evidence

Matthew has more than 25 years of experience in real-world evidence and observational, non-interventional research. He has led studies across the full life cycle—from startup through publication—supporting objectives that range from understanding a disease’s natural history to fulfilling global safety surveillance requirements. Matthew brings deep expertise in orphan disease programs, having overseen more than 25 long-term, global initiatives, as well as in disease and product registries, prospective pharmacoeconomic studies, and systematic literature reviews. Matthew leads the RWE Registries team, responsible for building the business and team. Prior to joining Aptitude Health, he held senior leadership roles at Parexel, Worldwide Clinical Trials, inVentiv Health Clinical, Quintiles Outcome, and ICON Clinical Research. Matthew holds a BA in sociology from Boston University, is a long-standing member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and is a frequent speaker at ISPOR, the Center for Business Intelligence, and related industry conferences.

Gerald Stanvitch, PhD

VP, Scientific Content

Cate Browning, PhD

VP, Global Medical Affairs

Erin Zingales Rau

VP, Account Services

Kelly Kocor

VP, People & Culture

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Bart Zygmond

VP, Finance

Bart brings a wealth of experience to the organization, having worked in the life sciences, pharmaceuticals, manufacturing, and service industries. With his expertise in financial reporting, US GAAP, SOX, cash flow modeling, and financial analysis, he plays a crucial role in the company’s financial management and strategy. Prior to joining Aptitude Health as VP, Finance, Bart held several controller positions: at Q2 Solutions, he oversaw the global finance team and financial operations, ensuring the accurate and timely financial reporting of the company. He also held controller positions at Domtar Inc and Veristat.

Eugene Vissers, MD

Senior VP, Global Scientific Content

Eugene is a seasoned medical doctor with over 20 years of international experience in pharma, consultancy, and agency environments. Eugene leads the US team of dedicated experts responsible for developing high-quality medical content. Prior to joining Aptitude Health, Eugene served as medical director at Ipsen and AstraZeneca. With both his medical degree and an MBA, Eugene brings a unique perspective to his role. His clinical background, combined with his business acumen, allows him to develop innovative strategies that drive results. Under Eugene’s leadership, the medical content team delivers scientific information of the highest quality, providing valuable insights to our clients around the world.

Adrian Barfield

VP, US Business Development

Kelley Hernandez

Executive VP, US Business Development

Kelley has over 18 years of experience in the oncology space. Kelley joined Aptitude Health after working with Cardinal Health, where she was part of the Healthcare and Analytics Division, and finished her tenure there with VitalSource™ (GPO division). As the leader of the strategic business development team for the US, Kelley brings a wealth of expertise to the organization. Her experience in the healthcare industry, combined with her ability to identify and capitalize on new business opportunities, is invaluable in driving the company’s growth and success. Kelley’s dedication to building strong relationships with life science partners is a testament to her commitment to delivering exceptional value to the healthcare industry.

Adam Sinensky, MBA

Chief Technology Officer

Adam has over 20 years of experience in the healthcare industry and an MBA in healthcare management. After 10 years as a strategy consultant to life science companies, Adam has spent the last decade as a product and strategy leader focused on bringing technology products to market across the payor, provider, and life sciences segments. By combining his business acumen and experience working directly with software developers, engineers, and data scientists, Adam has successfully led numerous product launches and enhancements from ideation to development and go-to-market initiatives. His product and change management expertise has led organizational shifts from services to technology at companies such as Change Healthcare and Datavant/Ciox. At Aptitude Health, Adam is responsible for growing our portfolio of product offerings by leveraging real-world data and artificial intelligence with our existing solutions and industry-leading Axess Network of healthcare providers. He also oversees our IT and cybersecurity teams.

Stefanie Daniels

Chief Commercial Officer

Stefanie is a seasoned healthcare executive with over 20 years of experience in oncology. She brings a wealth of knowledge and expertise to the organization. Stefanie joined Aptitude Health after spending over a decade as a senior director at Physicians’ Education Resource, an oncology CME vendor. During her tenure, she led and managed teams responsible for grant development/acquisition, program creation/execution, and faculty management. Stefanie’s deep understanding of the oncology industry and her ability to lead teams through complex projects make her a vital part of the organization’s success. Her dedication to providing high-quality solutions to our life science partners is a testament to her commitment to improving cancer patient care.

Jason Cash

Chief Financial Officer

Jason is an accomplished finance professional with over 20 years of experience in the pharmaceutical services industry. Throughout his career, he has demonstrated a keen ability to navigate high-growth organizations, delivering exceptional results. Before joining Aptitude Health, Jason served as the CFO of Veristat International, a global contract research organization. In this role, he led the financial strategy and played a pivotal role in driving the company’s growth and success. Jason’s wealth of experience and expertise in financial management make him an essential member of the leadership team. His strategic thinking and ability to drive results are highly respected within the industry.

Jez Moulding

Chief Executive Officer

Jez is a seasoned leader with over 20 years of experience in general management and regional president roles. He has a proven track record of success in the healthcare industry, having worked in the US, Japan, Australia, Korea, South Africa, France, and the UK for Sanofi, where he supported the launch of 10 new drugs across various therapeutic areas. As chief commercial officer at UDG Healthcare and EVP at Ashfield, Jez demonstrated his expertise in developing and implementing successful business strategies. He joined Aptitude Health from Pharmaspectra, an IQVIA business, where he served as CEO since 2018. Jez’s extensive experience in the pharmaceutical industry and his leadership skills make him an invaluable asset to the organization.

News & Events

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

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