May 30, 2024

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16 new cancer drugs approved by FDA in the first half of 2023

16 new cancer drugs approved by FDA in the first half of 2023



16 new cancer drugs approved by FDA in the first half of 2023. 

In the first half of 2023, FDA has approved a total of 16 new anti-cancer therapies, including targeting, immune checkpoint inhibitors, adoptive cellular immunotherapy, etc., covering Common types of solid and hematologic tumors.

The Medical Department of the Global Oncologist Network will refer to the FDA official website and the National Cancer Institute’s drug approval information in the middle and end of each year to sort out and update all targeted drugs approved for cancer, so as to bring you confidence in defeating cancer.

 


New anti-cancer drugs launched in the United States in the first half of 2023

01. Colorectal cancer — Tucatinib

  • The world’s first blockbuster new drug targeting HER2 colorectal cancer approved
  • Drug name: tucatinib (tucatinib)
  • Listing time: January 19, 2023
  • R & D company: Seagen
  • Drug introduction: Tucatinib is an oral small-molecule HER2 inhibitor that has shown anti-tumor activity in HER2-expressing tumor cells and has been approved for HER2-positive breast cancer in April 2020. On January 19, 2023, the FDA approved the launch of a new combination therapy, tucatinib (Tucatinib, Tukysa) combined with trastuzumab, for the treatment of adult patients with HER2-positive colorectal cancer (CRC)! It is worth mentioning that this is HER+ The first approved targeted therapy for colorectal cancer is a milestone!

Clinical data show that in the 84 patients who received tucatinib combined with trastuzumab, the confirmed objective response rate (ORR) was 38.1%, which means that these patients who failed multiple treatment options received a new combination After the regimen treatment, nearly 40% of the patients’ tumors were significantly shrunk by more than 30% or even disappeared!

16 new cancer drugs approved by  FDA in the first half of 2023

  Tucatinib was approved for marketing in the United States

02. Leukemia/lymphoma–zanubrutinib

  • Drug name: zanubrutinib (Brukinsa)
  • Listing time: January 19, 2023
  • R&D company: BeiGene USA
  • Drug introduction: On January 19, 2023, the US Food and Drug Administration (FDA) approved zanubrutinib (Brukinsa, BeiGene USA, Inc.) for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

03. Non-small cell lung cancer — pembrolizumab

  • Drug name: Pembrolizumab (Keytruda)
  • Listing time: January 26, 2023
  • R & D company: MSD
  • Drug introduction: On January 26, 2023, the FDA approved the new indication of the PD-1 inhibitor Pembrolizumab (Keytruda), which is used for stage Ib, II or IIIa non-small cell after surgical resection and platinum-based chemotherapy Adjuvant therapy for lung cancer. Approved clinical data show that compared with the placebo control group, adjuvant pembrolizumab can significantly prolong the disease-free survival of patients with completely surgically resected non-small cell lung cancer. The median disease-free survival period reached 58.7 months, nearly 5 years! The placebo group was only 34.9 months.

04. Breast cancer–Elacestrant

  • The first estrogen receptor degrader available for 2-line and 3-line ER+/HER2- breast cancer
  • Drug name: Elacestrant
  • Listing time: January 27, 2023
  • R&D company: Stemline
  • Drug description: elacestrant is a selective estrogen receptor degrader (SERD) for patients with ER+/HER2- advanced or metastatic breast cancer. Results from the pivotal Phase 3 EMERALD study demonstrated superior efficacy to current standard of care (SOC) agents in the overall study population and in patients whose tumors harbor ESR1 mutations. This is the first oral selective estrogen receptor degrader (SERD) available for 2- and 3-line ER+/HER2- advanced or metastatic breast cancer patients.

05. Lymphoma–LOXO-305

  • Drug name: Pirtobrutinib (LOXO-305)
  • Listing time: January 27, 2023
  • R & D company: Eli Lilly
  • Drug introduction: On January 27, 2023, the FDA issued an announcement to approve Eli Lilly’s pirtobrutinib (LOXO-305) for the treatment of relapsed or refractory mantle cell lymphoma after receiving at least 2 lines of systemic therapy (including BTK inhibitors). tumor.

Approved data show that among patients with relapsed/refractory mantle cell lymphoma who have previously received covalent BTK inhibitor therapy, pirtobrutinib achieved an overall response rate of 50%, and 13% of patients achieved Complete clinical remission.

It is worth mentioning that pirtobrutinib is the first BTK inhibitor that can be used in patients with mantle cell lymphoma who have previously received covalent BTK inhibitor therapy.

06. Breast cancer — Trodelvy

  • Drug name: sacituzumab govitecan-hziy (Trodelvy)
  • Listing time: February 3, 2023
  • R & D company: Geely
  • Drug introduction: On February 3, 2023, the FDA approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences) for unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 ( HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer with prior endocrine therapy and at least two additional systemic therapies in the metastatic setting.

07. Endometrial cancer–Jemperli

  • Drug name: dostarlimab-gxly (Jemperli, dostarlimab)
  • Listing time: February 9, 2023
  • R&D company: GlaxoSmithKline
  • Drug introduction: On February 9, 2023, the FDA approved dostarlimab-gxly (Jemperli, dostarimumab) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer. The approved data showed that the overall response rate (ORR) was 45.4%, of which the complete remission rate (CR) was 15.6%; 85.9% of patients had a duration of ≥12 months, and 54.7% of patients had a duration of ≥24 months.

08. Breast cancer — Verzenio

  • Drug name: abemaciclib (Abeciclib, Verzenio)
  • Listing time: March 3, 2023
  • R & D company: Eli Lilly
  • Drug presentation: On March 3, 2023, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio, Acibeli) for adjuvant treatment with endocrine therapy (tamoxifen or an aromatase inhibitor) Adult patients with hormone receptor (HR) positive, HER2 negative, node positive, early breast cancer at high risk of recurrence.

09. Children’s glioma — dabrafenib & trametinib

  • Drug name: dabrafenib (Tafinlar) and trametinib (Mekinist)
  • Listing time: March 16, 2023
  • R & D company: Novartis
  • Drug introduction: On March 16, 2023, the U.S. Food and Drug Administration approved dabrafenib (Tafinlar, Novartis) and trametinib (Mekinist, Novartis) for patients with low-grade glioma 1 year old and older (LGG) for the treatment of pediatric patients with BRAF V600E mutation who require systemic therapy. The FDA also approved new oral formulations of the two drugs for patients who cannot swallow pills.

10. Skin cancer – Zynyz

  • Drug name: retifanlimab-dlwr (Zynyz)
  • Listing time: January 27, 2023
  • R & D company: Incyte
  • Drug introduction: On March 22, 2023, the FDA granted accelerated approval to retifanlimab-dlwr (Zynyz) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

The approved data shows that the overall objective response rate (ORR) is as high as 52%, and 18% of them have achieved a complete response (CR), which means that all target lesions shown by imaging have disappeared!

Link to the original text: Just now! Another PD-1 has hit the market! More than 50% of patients’ tumors have shrunk significantly or even disappeared!

11. Urothelial carcinoma–Padcev

  • Drug name: enfortumab vedotin-ejfv (enfortumab)
  • Listing time: April 3, 2023
  • R&D company: Astellas Pharma
  • Drug introduction: On April 3, 2023, the FDA accelerated approval of enfortumab vedotin-ejfv (Padcev, Astellas Pharma) in combination with pembrolizumab (Keytruda, Merck) for the treatment of locally advanced or metastatic urinary tract disease not suitable for cisplatin-containing chemotherapy. skin cancer patients.

The approved data shows that the confirmed overall objective response rate (ORR) of 121 patients was 68% (95% CI: 59, 76), of which 12% had complete remission, which means that all target lesions showed by imaging have disappeared!

12. Lymphoma–Polivy

  • Drug name: polatuzumab vedotin-piiq (Polivy)
  • Listing time: April 19, 2023
  • R&D company: Genentech, Inc.
  • Drug Description: On April 19, 2023, the FDA approved polatuzumab vedotin-piiq (Polivy, Genentech, Inc.) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) In combination for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL), and International Prognostic Index (IPI) score is 2 or higher.

13. Lymphoma–Epkinly

  • Drug name: Epcoritamab-bysp (Epkinly)
  • Listing time: May 19, 2023
  • R&D company: Genmab US, Inc.
  • Drug introduction: On May 19, 2023, the FDA accelerated approval of epcoritamab-bysp (Epkinly, Genmab US, Inc.) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL caused by indolent lymphoma and high-grade B-cell lymphoma after two or more systemic therapies.

The approved data showed that the overall objective response rate (ORR) was as high as 61%, and 38% of them achieved a complete response (CR)!

14. Prostate cancer — Olaparib

  • Drug name: Olaparib (Lynparza)
  • Listing time: May 31, 2023
  • R&D company: AstraZeneca
  • Drug introduction: On May 31, 2023, the FDA approved olaparib (Lynparza, AstraZeneca) in combination with abiraterone and prednisone (or prednisolone) for the treatment of metastatic germline BRCA mutations (BRCAm) Adult patients with castration-resistant prostate cancer (mCRPC).

15. Lymphoma–Columvi

  • Drug name: glofitamab-gxbm (Columvi)
  • Listing time: June 15, 2023
  • R&D company: Genentech, Inc.
  • Drug Description: On June 15, 2023, the FDA granted accelerated approval to glofitamab-gxbm (Columvi) for the treatment of relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arises after two or more systemic therapies for follicular lymphoma.

The approved data shows that the overall objective response rate (ORR) is as high as 56%, and 43% of them achieved a complete response (CR), which means that nearly half of the patients showed that all target lesions disappeared on imaging!

16. Prostate cancer–Talzenna

  • Drug name: talazoparib (Talzenna)
  • Listing time: June 20, 2023
  • R&D company: Pfizer
  • Drug introduction: On June 20, 2023, the FDA approved talazoparib (Talzenna) in combination with enzalutamide for metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR) gene mutations.

The above new drugs are only a small part of the many research and development hotspots. There are still many new drug research and development, and innovative technologies are on the way.

It is believed that more drugs will be approved for marketing in the second half of 2023!

In addition, there are many New anti-cancer drugs under development also show broad-spectrum anti-cancer capabilities. The “Ark Assistance Program” can provide patients with free treatment opportunities for new drugs on the market and new drugs that are not on the market.

It is believed that with the continuous deepening of medical research, more and more new drugs will be developed and launched soon, and more patients will cross five years after another!

 

 

 

16 new cancer drugs approved by FDA in the first half of 2023

References:

US FDA official website

FDA Approvals in Oncology:April-June 2023.American Association for Cancer Research.30.06.2023.

FDA Approvals in Oncology:January-March 2023.American Association for Cancer Research.07.04.2023.

(source:internet, reference only)


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