December 1, 2022

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New anticancer drugs approved by FDA in the first half of 2021

New anticancer drugs approved by the FDA in the first half of 2021: 22 new therapies for the top ten cancers

 

 

New anticancer drugs approved by FDA in the first half of 2021. In the blink of an eye in 2021, in the past six months, domestic and international new anti-cancer drugs are on the market.

The FDA has approved a total of 22 new anti-cancer therapies, including targeted, immune checkpoint inhibitors, adoptive cellular immunotherapy, etc., covering For almost all types of cancer, it is worth mentioning that the two refractory targets of KRAS and EGFR20ins broke the deadlock in treatment, ushered in the first targeted drug, and many lucky patients waited for new hope and treatment. select.

 

Global Oncologist Network Medical Department will refer to the US FDA official website and the National Cancer Institute’s drug approval information every year at the middle and end of the year to sort out and update all cancer-approved targeted drugs, and bring everyone confidence in fighting cancer. (The following information is for reference only. The specific medication plan needs to be in accordance with the doctor’s advice. You can also call the Medical Department of Global Oncologist Network).

22 New anticancer drugs approved by FDA in the first half of 2021

 

 

 

 


Non-small cell lung cancer

 

01.  On May 29, 2021, the world’s first KRAS targeted drug AMG510 was launched on the market!

On May 29, 2021, it is effective against KRAS mutations. We have been looking forward to the two-year “revolutionary anticancer drug Sotorasib (AMG-510) finally obtained FDA approval and listed ahead of schedule! It is used to treat non-small people with KRAS G12c mutations. Cell lung cancer patients, these patients have received at least one pre-systemic treatment. At the same time, this drug also has its own name-Lumakras.

   This is the world’s first targeted drug for KRAS, which is of milestone significance! There will be countless cancer patients with KRAS mutations ushering in new hope of survival!

  • Drug name: Sotorasib (Lumakras AMG510)
  • Manufacturer: Amgen
  • FDA approval time: May 29, 2021
  • Indications: Non-small cell lung cancer patients with KRAS G12c mutation

 

 

02.   On May 21, 2021, Rybrevant, the first targeted drug for non-small cell lung cancer EGFR 20ins, was approved for marketing!

On May 21, 2021, the FDA officially approved Rybrevant (amivantamab-vmjw, codenamed JNJ6372) for use in adult patients with non-small cell lung cancer with insertion mutations in EGFR exon 20. This is the first targeted therapy for lung cancer patients with EGFR exon 20 insertion mutations. It is a major advancement in the medical field for these patients, and it is of milestone significance!

  • Drug name: Rybrevant (amivantamab-vmjw, code name JNJ6372)
  • Manufacturer: Janssen
  • FDA approval time: May 21, 2021
  • Indications: Adult patients with non-small cell lung cancer with EGFR exon 20 insertion mutation

 

 

03.  On March 3, 2021, the FDA approved the third-generation ALK inhibitor for first-line treatment

On March 3, 2021, the FDA newly approved the third-generation ALK inhibitor lorlatinib for the first-line treatment of ALK-positive non-small cell lung cancer!

Lorlatinib (LORBRENA) has been favored since its inception. The power of this third-generation targeted drug is that it can overcome all known ALK resistance mutations and can pass through the blood-brain barrier; it can inhibit crizoti Nine kinds of mutations that are resistant to nigra are still highly effective after being resistant to second-generation TKI drugs; at the same time, loratinib also has a strong blood-brain barrier permeability and a strong brain-entering effect, which is particularly suitable for Other ALK-resistant advanced NSCLC patients. This approval has enabled loratinib, a once-preserving drug, to become the first-line treatment of choice for ALK-positive patients. It is believed that it will bring better treatment effects and greater survival benefits to patients.

  • Drug name: Lorlatinib (LORBRENA)
  • Manufacturer: Pfizer
  • FDA approval time: March 3, 2021
  • Indications: ALK-positive non-small cell lung cancer first-line treatment

 

 

04.  On February 22, 2021, Libtayo, the fifth immunotherapy for non-small cell lung cancer, was approved as a first-line treatment

On February 22, 2021, the FDA approved the first-line PD-1 therapy cemiplimab for the first-line treatment of patients with advanced non-small cell lung cancer with PD-L1 expression >50%. This means that non-small cell lung cancer has ushered in the fifth immune checkpoint inhibitor, cemiplimab has successfully entered the first-line immune single-drug treatment of lung cancer, and advanced patients ushered in a new era of “going to chemotherapy”!

  • Drug name: LIBTAYO (cemiplimab)
  • Manufacturer: Sanofi & Regeneron
  • FDA approval time: February 22, 2021
  • Indications: PD-L1≥50% non-small cell lung cancer first-line treatment

 

 

05.  On February 3, 2021, the FDA accelerated the approval of terptinib for marketing

On February 3, 2021, the FDA accelerated the approval of Tepotinib (Tepotinib, Teppetko) for the treatment of adult patients with metastatic non-small cell lung cancer with skipping mutations in MET exon 14 (MET ex14).

  • Drug name: Tepotinib (Tepmetko)
  • Manufacturer: Merck
  • FDA approval time: February 3, 2021
  • Indications: Adult patients with metastatic non-small cell lung cancer with skipping mutation of MET exon 14 (MET ex14)

 

 

 


Stomach, esophageal cancer

 

06.  May 6, 2021, FDA approved pembrolizumab as the first-line treatment for gastric cancer

On May 6, 2021, the FDA approved a new combination regimen of pembrolizumab for the first-line treatment of patients with unresectable locally advanced or metastatic HER2-positive gastric and gastroesophageal junction adenocarcinoma.

  • Drug Name: Pembrolizumab
  • Manufacturer: Merck
  • FDA approval time: May 6, 2021
  • Indications: First-line treatment for patients with unresectable locally advanced or metastatic HER2-positive gastric and gastroesophageal junction adenocarcinoma

 

 

07.  On May 20, 2021, the FDA approved nivolumab for the neoadjuvant treatment of patients with esophageal cancer and gastroesophageal junction cancer

On May 20, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo, Bristol-Myers Squibb) for patients with residual esophagus or gastroesophageal junction (GEJ) cancer undergoing complete resection of neoadjuvant radiotherapy and chemotherapy.

  • Drug Name: Nivolumab
  • Manufacturer: Bristol-Myers
  • FDA approval time: May 20, 2021
  • Indications: Neoadjuvant chemotherapy and radiotherapy for patients with residual esophagus or gastroesophageal junction (GEJ) cancer

 

 

08.  On April 16, 2021, the FDA approved nivolumab combined with chemotherapy for the treatment of metastatic gastric cancer and esophageal adenocarcinoma

On April 16, 2021, the US FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) in combination with fluoropyrimidine and platinum-containing chemotherapeutics for the treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.

  • Drug Name: Nivolumab
  • Manufacturer: Bristol-Myers
  • FDA approval time: April 16, 2021
  • Indications: Combination of fluoropyrimidine and platinum-containing chemotherapeutics for the treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma

 

 

09.  March 22, 2021, FDA approved pembrolizumab to treat esophageal cancer or GEJ cancer

The US Food and Drug Administration approved pembrolizumab (Keytruda) combined with platinum and fluoropyrimidine chemotherapy to treat metastatic or locally advanced esophagus or gastroesophagus (GEJ) (the tumor center is located 1 to 5 cm above the gastroesophageal junction Patients)) cancers that are not suitable for surgical resection or radical radiotherapy and chemotherapy.

  • Drug name: Pembrolizumab (Keytruda)
  • Manufacturer: Merck
  • FDA approval time: March 22, 2021
  • Indications: combined platinum and fluoropyrimidine chemotherapy for metastatic or locally advanced esophageal or gastroesophageal cancer

 

 

10.  On January 15, 2021, Enhertu was approved for HER2-positive stomach or gastroesophageal cancer

On January 15, 2021, the US Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for locally advanced or metastatic HER2-positive gastric or gastroesophageal patients who have previously received trastuzumab-based therapy (GEJ) Adult patients with adenocarcinoma.

  • Drug name: Enhertu
  • Manufacturer: AstraZeneca
  • FDA approval time: January 15, 2021
  • Indications: Adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have previously received trastuzumab-based therapy.

 

 

 


Cholangiocarcinoma

 

11.  On May 28, 2021, the FDA accelerated the approval of infigratinib for the treatment of metastatic cholangiocarcinoma

On May 28, 2021, the US Food and Drug Administration accelerated the approval of infigratinib (Truseltiq, QED Therapeutics, Inc.), which is a kinase inhibitor for previously treated, unresectable locally advanced or metastatic Adult patients with FGFR2 fusion cholangiocarcinoma.

  • Drug name: infigratinib
  • Manufacturer: QED Therapeutics, Inc
  • FDA approval time: May 28, 2021
  • Indications: Treated, unresectable, locally advanced or metastatic FGFR2 fusion cholangiocarcinoma adult patients.

 

 

 


Kidney Cancer

 

12.  March 10, 2021, FDA approved tivozanib for the treatment of relapsed or refractory advanced renal cell carcinoma

The US Food and Drug Administration approved tivozanib (Fotivda, AVEO Pharmaceuticals, Inc.), a kinase inhibitor for relapsed or refractory advanced renal cell carcinoma (RCC) that has received two or more systemic treatments in the past Adult patients.

  • Drug name: tivozanib
  • Manufacturer: AVEO Pharmaceuticals, Inc
  • FDA approval time: March 10, 2021
  • Indications: Adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) who have received two or more systemic treatments in the past.

 

 

13.  On January 22, 2021, the FDA approved nivolumab combined with cabozantinib for the treatment of advanced renal cell carcinoma

The US Food and Drug Administration approved the combination of nivolumab (Opdivo, Bristol-Myers Squibb) and cabozantinib (Cabometyx, Exelixis) as the first-line treatment for patients with advanced renal cell carcinoma (RCC).

  •   Drug Name: Nivolumab+Cabotinib
  •    Manufacturer: Bristol-Myers
  •    FDA approval time: January 22, 2021
  •    Indications: First-line treatment for patients with advanced renal cell carcinoma (RCC)

 

 

 


Endometrial cancer

 

14.  On April 22, 2021, the FDA accelerated the approval of dostarlimab-gxly for dMMR endometrial cancer

The U.S. Food and Drug Administration approved accelerated approval of dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with recurrent mismatch repair defects (dMMR) or advanced endometrial cancer, which progresses after platinum-based treatment.

  Drug name: Jemperli

   Manufacturer: GlaxoSmithKline LLC

   FDA approval time: April 22, 2021

   Indications: Adults with recurrence of mismatch repair defects (dMMR) or advanced endometrial cancer, progress after platinum-based treatment

 

 

 


Triple negative breast cancer

 

15.  On April 7, 2021, the FDA regularly approved sacituzumab govitecan for the treatment of triple-negative breast cancer

The US Food and Drug Administration regularly approves sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) patients who have received two or more previous systemic therapies, at least one of them Used for metastatic treatment of diseases.

  • Drug name: Trodelvy
  • Manufacturer: Immunomedics Inc
  • FDA approval time: April 7, 2021
  • Indications: Patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more previous systemic treatments, at least one of which is used for metastatic disease

 

 

 


Advanced 0Urothelial Carcinoma

 

16.  On April 13, 2021, the FDA accelerated the approval of sacituzumab govitecan for advanced urothelial cancer

On April 13, 2021, the FDA accelerated the approval of sacituzumab govitecan for advanced urothelial cancer.

  Drug name: Trodelvy

   Manufacturer: Immunomedics Inc

   FDA approval time: April 13, 2021

   Indications: advanced urothelial carcinoma

 

 

 


Basal cell carcinoma

 

17.  On February 9, 2021, the FDA approved cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma

On February 9, 2021, the FDA approved cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma.

  • Drug name: cemiplimab-rwlc
  • Manufacturer: Saishengyuan
  • FDA approval time: February 9, 2021
  • Indications: advanced urothelial carcinoma

 

 

 


Multiple myeloma

 

18.   on  March 31, 2021 FDA approved isatuximab-irfc for multiple myeloma

The US Food and Drug Administration approved isatuximab-irfc (Sarclisa, Sanofi-Aventis USA, LLC) in combination with carfilzomib and dexamethasone for the treatment of relapses that have received one to three previous treatments Or adult patients with refractory multiple myeloma.

 

 

19.  On March 26, 2021, the FDA approved idecabtagene viceucel to treat multiple myeloma

On March 26, 2021, the US FDA approved idecabtagene vicleucel (Abecma, Bristol Myers Squibb) for the treatment of adult patients with relapsed or refractory multiple myeloma. These patients have received four or more lines of treatment, including Immunomodulators, proteasome inhibitors and anti-CD38 monoclonal antibodies. This is the first cell-based gene therapy approved by the FDA for multiple myeloma.

  • Drug name: idecabtagene
  • Manufacturer: Bristol Myers Squibb
  • FDA approval time: March 26, 2021
  • Indications: multiple myeloma

 

 

 


Lymphoma

 

20.  On April 23, 2021, the U.S. Food and Drug Administration accelerated approval of loncastuximab tesirine-lpyl for large B-cell lymphoma

On April 23, 2021, the U.S. Food and Drug Administration accelerated the approval of loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics SA), a CD19-targeted antibody and alkylating agent conjugate for relapse or refractory treatment after treatment. Adult patients with B-cell lymphoma. Two or more systemic treatments, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL caused by low-grade lymphoma, and high-grade B-cell lymphoma.

  • Drug name: Zynlonta
  • Manufacturer: ADC Therapeutics SA
  • FDA approval time: April 23, 2021
  • Indications: multiple myeloma

 

 

21. On March 25, 2021, Yescarta was approved for follicular lymphoma

The US Food and Drug Administration has accelerated the approval of axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) for adult patients with relapsed or refractory follicular lymphoma (FL) after receiving two or more lines of systemic therapy.

  • Drug name: axicabtagene ciloleucel
  • Manufacturer: Kite Pharma
  • FDA approval time: March 25, 2021
  • Indications: refractory follicular lymphoma

 

 

22.  February 5, 2021, FDA approved Breyanzi for large B cell lymphoma

The US Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after receiving two or more lines of systemic therapy, including Diffuse large B-cell lymphoma (DLBCL) (including DLBCL derived from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma .

  • Drug name: Breyanzi
  • Manufacturer: Juno Therapeutics
  • FDA approval time: February 5, 2021
  • Indications: large B cell lymphoma

 

 

Sum up: 

Experts believe that with the continuous deepening of medical research, more and more new drugs will soon be developed and marketed.

 

 

(source:internet, reference only)


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