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New Cancer Drugs Approved in 2023

In 2023, the U.S. Food and Drug Administration (FDA) approved several new cancer drugs that offer promising treatment options for patients. Here are some of the key cancer drug approvals from the past year:

Pembrolizumab Plus Chemotherapy for Advanced or Recurrent Endometrial Cancer
In June 2023, the FDA approved the combination of pembrolizumab (Keytruda) and chemotherapy (carboplatin and paclitaxel) for the treatment of adults with primary advanced or recurrent endometrial carcinoma. This approval includes patients with mismatch repair-proficient or -deficient disease[1].

Osimertinib for Stage III NSCLC with EGFR Mutations
Also in June 2023, the FDA granted priority review to osimertinib (Tagrisso) for the treatment of stage III non-small cell lung cancer (NSCLC) with EGFR mutations. This supplemental new drug application is seeking approval for osimertinib in this earlier stage of NSCLC[1].

Lecanemab for Alzheimer’s Disease
In January 2023, the FDA approved lecanemab-irmb (Leqembi) to treat Alzheimer’s disease. Lecanemab is the first drug that has been shown to slow the progression of this devastating neurodegenerative disease[2].

Pirtobrutinib for Relapsed/Refractory Mantle Cell Lymphoma
The FDA approved pirtobrutinib (Jaypirca) in January 2023 to treat adults with relapsed or refractory mantle cell lymphoma who have had at least two prior lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor[2].

Elacestrant for ER+, HER2- Advanced Breast Cancer with ESR1 Mutations
Also in January 2023, the FDA approved elacestrant (Orserdu) to treat estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer in adults with disease progression following at least one line of endocrine therapy[2].

These are just a few examples of the many new cancer drugs that received FDA approval in 2023, providing patients with additional treatment options. As cancer research continues to advance, we can expect to see more innovative therapies reach the market in the coming years.

[1] https://www.oncnursingnews.com/view/what-new-cancer-drugs-were-approved-in-2023-
[2] https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2023

Citations:
[1] https://www.oncnursingnews.com/view/what-new-cancer-drugs-were-approved-in-2023-
[2] https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2023
[3] https://www.aacr.org/blog/2024/04/03/fda-approvals-in-oncology-january-march-2024/
[4] https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
[5] https://medicine.yale.edu/news-article/yale-crrit-cancer-drug-guidelines-fda-approvals/
[6] https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications
[7] https://www.cancer.gov/about-cancer/treatment/drugs/lung
[8] https://www.cancer.gov/news-events/cancer-currents-blog/2024/fda-amtagvi-til-therapy-melanoma
[9] https://www.fda.gov/drugs/resources-information-approved-drugs/other-cancer-accelerated-approvals
[10] https://www.pennmedicine.org/research-at-penn/cancer-fda-approvals
[11] https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2824%2900152-9/fulltext
[12] https://www.fda.gov/drugs/resources-information-approved-drugs/withdrawn-cancer-accelerated-approvals
[13] https://www.cancer.gov/about-cancer/treatment/types/targeted-therapies/approved-drug-list
[14] https://www.biospace.com/article/biospace-fda-decision-tracker-2023-biomarin-celltrans-pfizer-and-opko-health/
[15] https://www.aacr.org/blog/2023/09/29/fda-approvals-in-oncology-july-september-2023/