Highlights of EMA approvals in 2023 focus on cancer medicines

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In its ‘2023 Human Medicines Highlights’, the European Medicines Agency (EMA) provided a comprehensive overview of key recommendations for the approval of medicines in various therapeutic areas. Notably, the report highlighted significant advancements in cancer treatment approvals, including cancer biosimilar.

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In 2023, the EMA recommended 77 medicines for marketing authorization, including 39 with novel active ingredients previously unapproved in the EU. Some of these medications notably address public health concerns or showcase innovative advancements.

EMA plays a pivotal role in the evaluation and regulation of medicines within the European Union, with the aim to improve patient access to vital treatments while ensuring safety and efficacy standards are met.

Until 2023, EMA has recommended the approval of 93 biosimilars [1], with eight of them recommended in 2023 alone, they are:

1. Cancer
Herwenda (trastuzumab)

2. Haematology/Haemostaseology
Bekemv (eculizumab)
Epysqli (eculizumab)

3. Immunology/ Rheumatology/ Transplantation
Tyenne (tocilizumab)
Uzpruvo (ustekinumab)

4. Neurology
Tyruko (natalizumab)

5. Ophthalmology
Rimmyrah (ranibizumab)
Yesafili (aflibercept)

The latest estimates, released on 1 February 2024 by the World Health Organization’s International Agency for Research on Cancer, predict that there will be over 35 million new cancer cases in 2050, representing a 77% increase from the estimated 20 million cases in 2022 [2].

Among the 2023 EMA marketing authorization, 25 were for cancer treatment. Authorization of new medicines is essential for advancing public health as they offer new opportunities to treat certain diseases. Table 1 presents a selection of cancer medicines recommended for approval in 2023, showcasing significant advancements in their respective therapeutic areas.

Table 1: EMA recommended approval of cancer medicines in 2023
Product name Target/Therapeutic area
Columvi (glofitamab) and Tepkinly (epcoritamab) Diffuse large B-cell lymphoma, an aggressive type of non-Hodgkin lymphoma
Elrexfio (elranatamab) Adult patients with relapsed or refractory multiple myeloma
Finlee (dabrafenib) in combination with Spexotras (trametinib) Paediatric patients aged one year and older with glioma, a type of brain tumour
Jaypirca (pirtobrutinib) Relapsed or refractory mantle cell lymphoma which develops when B-cells, a type of white blood cell that makes antibodies, become abnormal
Krazati (adagrasib) Adults with advanced non-small cell lung cancer with a G12C mutation in the KRAS gene whose disease has worsened after at least one systemic treatment
Lytgobi (futibatinib) Cholangiocarcinoma or bile duct cancer
Omjjara (momelotinib) For myelofibrosis, a rare blood cancer that affects the bone marrow
Pedmarqsi (sodium thiosulfate) For the prevention of ototoxicity induced by cisplatin chemotherapy in children from one month up to 18 years of age
Talvey (talquetamab) Adult patients with relapsed and refractory multiple myeloma, a rare cancer of the bone marrow


The approval of several cancer treatment medicines in 2023, as outlined in Table 1, marks a significant milestone in the field of oncology and broader public health. These medications, ranging from novel targeted therapies to biosimilars, represent promising advancements in the fight against cancer, addressing diverse forms of the disease such as lymphoma, multiple myeloma, lung cancer, and more.

Related article
ASCO policy statement on biosimilars and interchangeables in oncology updated

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 14]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars in cancer treatment in Europe and the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 14]. Available from: www.gabionline.net/reports/biosimilars-in-cancer-treatment-in-europe-and-the-us

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