October 20, 2021

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New anti-cancer medicines approved by the FDA in 2020

New anti-cancer medicines approved by the FDA in 2020

New anti-cancer medicines approved by the FDA in 2020. In 2020, the FDA approved nearly 50 new therapies, covering the top ten solid tumors.

New anti-cancer medicines approved by the FDA in 2020. In 2020, the FDA approved nearly 50 new therapies, covering the top ten solid tumors.

2020 is coming to an end. Many new medicines were released to the market this year ! Although many countries are still under the haze of the pneumonia epidemic, the US FDA was not affected  to appove new medicines at all. Instead, it has rushed forward and the good news continues. It is the people who recognize that cancer patients are susceptible to coronavirus pneumonia. At this critical moment, the FDA is still committed to cancer patients and makes every effort to accelerate the development of oncology products.

The Medical Department of Global Oncologist Network will refer to the official website of the US FDA and the National Cancer Institute’s drug approval information every year to sort out and update all cancer-approved targeted medicines, and bring everyone confidence in fighting cancer. In 2020, the FDA approved nearly 50 new therapies, covering the top ten solid tumors. There are many lucky patients waiting for new hopes and treatment options. The new year is about to enter. Let us take a look. Which medicines will break through the barrier in 2020 and be approved?

Non-small cell lung cancer

1 On May 6, 2020, the first MET inhibitor camatinib was approved for marketing!

METex14 mutations occur in 3-4% of newly diagnosed advanced NSCLC cases, which is a type of lung cancer with a particularly poor prognosis. As an oral, highly selective small molecule MET inhibitor, camatinib was released on May 6, 2020 It was approved for marketing by the US FDA on Japan, becoming the first targeted drug for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with MET 14 jumping mutations.
Drug name: Capmatinib (Camatinib INC280)
Manufacturer: Novartis
FDA approval time: May 6, 2020
Indications: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) with skip mutations in exon 14 of MET, including first-line treatment (naïve) patients and previously treated (treated) patients

2 On May 8, 2020, the first RET inhibitor, Serpatinib, was launched

In non-small cell lung cancer, only 1%-2% of patients have RET gene fusion, most of which are fusion with KIF5B gene, which means that RET gene and KIF5B gene are fused together to form a new gene. The emergence of cancer cells will cause uncontrolled malignant growth. On May 8, 2020, the U.S. Food and Drug Administration (FDA) accelerated the approval of selpercatinib (RETEVMO, Eli Lilly and Company), becoming the world’s first precision therapy for cancer patients with RET gene mutations.
Drug name: Selpercatinib (LOXO-292, Serpatinib)
Manufacturer: Eli Lilly
FDA approval time: May 8, 2020
Indications:
Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC);
Adult and pediatric patients ≥12 years old with systemic or recurrent RET mutant medullary thyroid carcinoma (MTC) need systemic therapy;
Adult and pediatric patients ≥12 years of age with advanced or metastatic RET fusion-positive thyroid cancer require systemic therapy and are refractory to radioactive iodine (if appropriate, radioactive iodine is required).

3 On May 18, 2020, atezolizumab first-line treatment of non-small cell lung cancer

Atezolizumab (Atezolizumab) is a monoclonal antibody that targets the PD-L1 protein. Atezolizumab binds to PD-L1 expressed on tumor cells and tumor infiltrating immune cells, blocking its interaction with PD-1 and B7.1 receptors. By inhibiting PD-L1, T cells can be activated to destroy tumor cells.
Drug name: Tecentriq (atezizumab)
Manufacturer: Roche
FDA approval time: May 18, 2020
Indications: First-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC), these patients have tumors with high PD-L1 expression (PD-L1≥50%), but no EGFR or ALK gene mutations.

4 On May 22, 2020, brigatinib first-line treatment of ALK+ non-small cell lung cancer

Drug name: Alunbrig (brigatinib)
Manufacturer: Takeda Pharmaceutical
FDA approval time: May 22, 2020
Indications: First-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) with ALK-positive genetic testing

5 On May 26, 2020, O+Y was approved for the first-line treatment of non-small cell lung cancer

The US Food and Drug Administration (FDA) approved nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) in combination with 2 cycles of platinum-based dual chemotherapy for metastasis or Patients with recurrence of non-small cell lung cancer (NSCLC), without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor abnormalities.
Drug name: Nivolumab / Ipilimumab
Manufacturer: Bristol-Myers Squibb
FDA approval time: May 26, 2020
Indications: For the first-line treatment of patients with EGFR/ALK-negative advanced NSCLC (non-small cell lung cancer).

6 On May 29th, ramucirumumab + erlotinib first-line treatment of EGFR non-small cell lung cancer

Drug name: ramucirumab + erlotinib
Manufacturer: Eli Lilly
FDA approval time: May 29, 2020
Indications: Cyramza (ramucirumab) combined with erlotinib, first-line treatment with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) metastatic non-small cells First-line treatment for lung cancer (NSCLC).
Clinical data: The latest FDA approval of ramucirumab is based on data from a phase III clinical study. Compared with the control group, the combination therapy of ramucirumab has a progression-free survival of 19.4 months for NSCLC. The control group was only 12.4 months old.

7 On September 4, 2020, the second RET inhibitor Presitinib was launched

On September 5, 2020, Praalsetinib (code-named BLU-667, Presitinib), the world’s second excellent RET inhibitor, was approved by the FDA and officially launched. At the same time, this medicine also has its own name-GAVRETO! This is currently the only RET inhibitor that only needs to be taken orally once a day, and it has shown a long-lasting effect, and some patients have been completely relieved! I have to say that the RET fusion patients finally ushered in the spring!
Drug name: Pralsetinib (BLU-667, Presitinib)
Manufacturer: Blueprint Medicines
FDA approval time: September 4, 2020
Indications: For the treatment of adult patients with RET fusion-positive metastatic non-small cell lung cancer (NSCLC) approved by the FDA.

Small Cell Lung Cancer

1 June 16, 2020: 30 years of sharpening a sword! Blockbuster new chemotherapeutics for small cell lung cancer are approved for marketing!

On June 16, 2020, the FDA approved the listing of Lurbinectedin (Zepzelca) for the treatment of adult patients with metastatic small cell lung cancer who have progressed after platinum-based chemotherapy.

The approval is based on the results of the Phase II NCT-2454972 trial, which showed that the overall response rate of patients treated with Lurbinectedin was 35.2%, the disease control rate was 68.6%, and the median duration of response was 5.3 months.

2 March 21, 2020: Small cell lung cancer ushered in a new first-line therapy, valuzumab launched!

On March 21, 2020, the FDA approved Durvalumab (Durvalumab, Imfinzi) for the first-line treatment of adult patients with extensive stage small cell lung cancer. It can be combined with chemotherapy regimens including etoposide, carboplatin, or cisplatin. use.

The approval is based on the results of the Phase III CASPIAN trial, which showed that the median overall survival of patients treated with devaluzumab + chemotherapy was 13.0 months, and the overall response rate was 68%; the median overall survival of patients receiving chemotherapy only It was 10.3 months, and the overall remission rate was 58%.

Breast cancer

1 On April 17, 2020, the lifetime is significantly extended! Tucatinib, a new breast cancer medicine, is shockingly launched!

On April 17, 2020, Tucatinib ((Tukysa) was accelerated by the FDA four months in advance and approved for marketing. It is used in combination with trastuzumab and capecitabine for the treatment of locally advanced unresectable or metastatic HER2 Patients with positive breast cancer, including patients with brain metastases, have received at least three previous HER2 guidance medicines separately or in combination.
Drug name: tucatinib (tucatinib)
Manufacturer: Genetics
FDA approval date: April 17, 2020
Indications: Combine trastuzumab and capecitabine for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases who have received at least three previous HER2 separately or in combination Guide medicines

2 On April 22, 2020, the world’s first triple-negative breast cancer antibody conjugate medicine Trodelvy hits!

On April 22, 2020, Immunomedics announced the listing of its antibody-conjugated drug Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with metastatic triple negative breast cancer (mTNBC) who have previously received at least 2 therapies. Trodelvy is an FDA The first approved antibody-conjugated drug for the treatment of triple-negative breast cancer is also the world’s first approved antibody-conjugated drug targeting human trophoblast cell surface antigen 2 (Trop-2).
Drug name: Trodelvy (sacituzumab govitecan-hziy, IMMU-132)
Manufacturer: Immunomedics
FDA approval time: April 22, 2020
Indications:
Adult patients with metastatic triple-negative breast cancer (mTNBC) who have previously received at least 2 therapies.

3 November 13, 2020: Keytruda was first approved for triple negative breast cancer

On November 13, 2020, the U.S. Food and Drug Administration (FDA) approved the accelerated approval of Merck’s (MSD) blockbuster PD-1 inhibitor Keytruda in combination with chemotherapy for tumor expression PD-L1 ([CPS]≥ 10. Patients with unresectable locally recurrent or metastatic triple-negative breast cancer (TNBC) confirmed by FDA-approved testing.

This is the first time that Keytruda has received FDA approval for the treatment of breast cancer, and represents an important milestone in its development.

Gastrointestinal stromal tumor

1 May 15, 2020: The risk of death is reduced by 85%, and the new drug ripretinib for gastrointestinal stromal tumors is launched

On May 15, 2020, the U.S. Food and Drug Administration announced that it had approved protein kinase inhibitor Qinlock (ripretinib, ripretinib) tablets, becoming the first innovative therapy specifically designed to treat advanced gastrointestinal stromal tumors (GIST) with 4 lines. This medicine is indicated for adult patients with GIST who have received more than 3 protein kinase inhibitor therapies, including imatinib.
Drug name: ripretinib (ripretinib DCC-2618)
Manufacturer: Deciphera Pharmaceuticals
Priority approval time: February 13, 2020
FDA is expected to rule: August 13, 2020
Approval time: Accelerated approval on May 15, 2020
Indications: Patients with advanced gastrointestinal stromal tumor (GIST)

2 January 9, 2020: FDA approves Avapritinib for gastrointestinal stromal tumors

On January 9, 2020, the U.S. Food and Drug Administration (FDA) approved Avapritinib, (AYVAKIT TM) for use in adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) who have platelets Derived growth factor receptor alpha (PDGFRA) exon 18 mutations, including the D842V mutation.

The approval is based on the efficacy results of the Phase I NAVIGATOR trial and comprehensive safety data from multiple studies of avapritinib. In a specific population of patients with PDGFRA exon 18 mutations, avapritinib caused an overall effective rate of 84%. 7% of patients had a complete remission and 77% had a partial remission. Specifically for the D842V mutation in PDGFRA patients, the effective rate is 89%, the complete remission is 8%, and the partial remission is 82%.


Cholangiocarcinoma

1 April 17, 2020: The world’s first bile duct cancer targeted drug pemigatinib debuts

On April 17, 2020, patients with cholangiocarcinoma ushered in great news! The FDA has accelerated the approval of Incyte’s Pemazyre (pemigatinib) for the treatment of previously treated patients with locally advanced or metastatic cholangiocarcinoma carrying fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement. The approval date on June 30 was advanced by one and a half months. This is also the first targeted therapy for cholangiocarcinoma approved by the FDA.
The effective ORR of this drug in the second-line treatment of patients with cholangiocarcinoma is 35.5%, and the disease control rate is 82%, making it the first targeted drug in the history of cholangiocarcinoma! It has epoch-making significance!
Drug name: Pemazyre (pemigatinib)
Manufacturer: Incyte
FDA’s estimated ruling time: May 30, 2020
Approval time: Accelerated approval on April 17, 2020
Indications: Patients with locally advanced or metastatic cholangiocarcinoma who have been treated with fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement

Esophageal cancer

1 June 11, 2020: FDA approves Opdivo for esophageal cancer

On June 11, 2020, the FDA approved nivolumab for the treatment of advanced recurrent or metastatic adult patients with esophageal squamous cell carcinoma that has progressed after chemotherapy. The approval is based on the results of a phase III clinical trial, which showed that nivolumab improved overall survival compared to standard chemotherapy. Opdivo is the first tumor immunotherapy approved for the above-mentioned ESCC patient population regardless of PD-L1 expression level.

Colorectal cancer

1 April 8, 2020: BRAF colorectal cancer patients usher in the first targeted therapy

On April 8, 2020, Pfizer announced that the U.S. FDA has approved Braftovi® (encorafenib, Cornefinil) and Erbitux® (cetuximab, cetuximab) combination medication regimen (Braftovi two-drug regimen). For the treatment of patients with metastatic colorectal cancer (mCRC) with BRAF V600E mutation. These patients have already received one or two pre-treatments. This approval also makes the Braftovi two-drug regimen the first targeted therapy approved by the FDA for mCRC patients with BRAF gene mutations.

2 June 29, 2020: FDA approves Keytruda as the first-line treatment for colorectal cancer

On June 29, 2020, the FDA approved the use of pembrolizumab (KEYTRUDA, Merck & Co.) as the first-line treatment for unresectable or metastatic microsatellite instability (MSI-H) or mismatch repair defect (dMMR) colorectal cancer For patients, the approval was based on the results of a phase II clinical trial, which showed that the time before disease progression in patients receiving pembrolizumab almost doubled compared to patients receiving standard treatment.

Liver cancer

1 March 10, 2020: FDA approves O+Y regimen to treat liver cancer

In March 2020, the FDA approved the combined use of nivolumab and ipilimumab to treat patients with hepatocellular carcinoma. Phase I/II clinical trials showed that the drug can shrink tumors in 33% of patients who fail standard treatment.

2 May 29, 2020: FDA approves atezolizumab for first-line treatment of liver cancer

In May 2020, the FDA approved atezolizumab combined with bevacizumab (Avastin) for the initial treatment of metastatic hepatocellular carcinoma that cannot pass surgery.

Thyroid cancer

1 December 2, 2020: FDA approves Gavreto for medullary thyroid cancer

On December 2, 2020, the FDA announced that it has accelerated the approval of Presitinib (Pralsetinib, Gavreto, also known as the “star drug” BLU-667) extended indications for the treatment of late or metastatic RET mutations Adult patients with medullary thyroid cancer and children over 12 years old, and patients with refractory advanced or metastatic thyroid cancer who are positive for RET fusion mutations and require systemic therapy combined with radioiodine therapy. This is the second indication for Presitinib after non-small cell lung cancer.

Unlimited cancer

1 June 16, 2020: Keytruda’s second non-restricted cancer indication approved

In June 2020, the FDA approved pembrolizumab to treat adult and pediatric patients with unresectable or metastatic solid tumors with high tissue tumor mutational burden (TMB-H) ≥10 mutations/megabase (using FDA-specified testing). The approval is based on data from a phase II clinical trial. Treatment with pembrolizumab can shrink 30% of unresectable or metastatic tumors.

With the continuous deepening of medical research, more and more new medicines are about to be developed and marketed, and more patients will fight with cancers better!

(source:yaochuank)