In February, the United States, China and Canada summarized the new drugs listed since 2020, including two drugs listed in China. Let me update you on these two drugs first:
Atelizumab (Tecentriq) in the treatment of small cell lung cancer; By the end of April, this medicine was no longer available in China.
Emetizumab (Kadcyla) is used for HER-2 positive breast cancer. Patients can already buy this medicine in Shanghai Meizhong Jiahe Cancer Clinic. Please call 0 10-5957 5778 for the specific drug price and donation plan.
Recently, many new drugs have been put on the market. This paper lists 1 1 new drugs for cancer species, among which 6 "firsts/firsts" have been witnessed. The first time means "epoch-making". Let's go and find it together. Welcome to forward the collection.
If you have more information about anticancer drugs, please leave a message at the end of the article to share. )
Abbreviation comparison table in text
NMPA: National Medical Products Administration
FDA: US Food and Drug Administration
Objective remission rate
DCR: disease control rate
Reaction duration
OS: overall survival rate
PFS: progression-free survival
lung cancer
Amitinib mesylate tablets
-China was approved.
This is the first third-generation EGFR drug independently developed and marketed in China, and the second in the world after osetinib.
Approved indications: NMPA approved amitriptyline for adult patients with locally advanced or metastatic non-small cell lung cancer, who had previously been treated with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) or developed disease after treatment, and were confirmed to have EGFR T790M mutation.
Drug effect: 244 patients were included in the phase II study of amitriptyline. The results showed that the ORR and DCR of second-line treatment for advanced non-small cell lung cancer with EGFR T790M positive were 68.4% and 93.4% respectively.
Duvazumab combined with etoposide and carboplatin or cisplatin
-the United States was approved.
Approved indications: durvalumab (also known as "drug I") approved by FDA combined with etoposide &; Carboplatin or cisplatin as first-line treatment for patients with extensive small cell lung cancer [1].
Drug action: Caspian Sea research (NCT03043872) shows that,
gastric cancer
Nivolumab (Oppo, drug O) (new indication)-approved by China.
O drug is the first immunotherapy drug for patients with gastric adenocarcinoma and gastroesophageal junction gland.
Approved indications: NMPA approved Nivolumab for advanced or recurrent gastric adenocarcinoma and gastric esophageal junction adenocarcinoma after receiving two or more systemic treatment schemes.
liver cancer
Karilizumab (new indication)-approved by China
This is the first approved immunotherapy for liver cancer in China!
Approved indications: NMPA approved Karelizumab for the treatment of advanced hepatocellular carcinoma patients receiving sorafenib and/or oxaliplatin chemotherapy.
From May 2065438 to May 2009, the drug was approved for the treatment of recurrent/refractory classic Hodgkin's lymphoma in China.
Efficacy: Up to now, the world's largest clinical study on second-line and above treatment of liver cancer with PD- 1 monoclonal antibody shows that the ORR of Karelizumab reaches14.7%; DCR is 44.2%; The OS rate of 6 months was 74.4%, and that of 12 months was 55.9%.
Nivolumab combined with ipilimumab- approved by the United States
Drug indications: FDA approved nivolumab combined with ipilimumab in the treatment of hepatocellular carcinoma patients receiving sorafenib.
Drug effect: CheckMate -040 research shows that patients treated with this combination scheme:
(1) ORR was 3 1%, in which the complete remission rate was 8%(4/49) and the partial remission rate was 24% (12/49).
(2) DOR is 17.5 months; Among the patients in remission stage, 88%≥6 months, 56%≥ 12 months and 3 1%≥24 months.
Squamous cell carcinoma of head and neck
Cetuximab combined with chemotherapy-approved by China
Indications: NMPA approved cetuximab injection combined with platinum and fluorouracil chemotherapy for the first-line treatment of recurrent and/or metastatic head and neck squamous cell carcinoma (R/M SCCHN).
Drug action: 442 patients with head and neck tumors were included in the EXTREME study, and were divided into experimental group (cetuximab+cisplatin or carboplatin+fluorouracil) and control group (cisplatin or carboplatin+fluorouracil).
Urothelial carcinoma
Tenerizumab (new indication)-approved in China.
This is the first PD- 1 monoclonal antibody listed in the field of urothelial cancer in China.
Approved indications: NMPA approved tillizumab for the treatment of locally advanced or metastatic urothelial cancer.
From 20 19 to 12, the drug was approved for the treatment of recurrent or refractory classic Hodgkin's lymphoma (R/R cHL).
Drug action: The study of BGB-A3/KOOC-0/7-204 showed that 9.9% (/KOOC-0/0) of the evaluable patients achieved complete remission,/KOOC-0/4.9% (/KOOC-0) And all patients with different baseline conditions showed clinical remission.
breast cancer
sacituzumab govitecan(Trodelvy)
-the United States was approved.
In the drug summary article in February, it was mentioned that sacituzumab govitecan(Trodelvy) was predicted by nature sub-journal to be listed in 2020. Finally, the FDA accelerated the approval of its listing.
This is the first antibody-coupled drug approved by FDA to treat triple negative breast cancer.
Approved indications: It is used to treat adult patients with metastatic triple negative breast cancer (triple negative breast cancer) who have received at least 2 treatments in the past.
Drug effect: Phase II clinical trial showed that among 108 patients with triple negative breast cancer, the ORR was 33.3% and the median DOR was 7.7 months [2].
colorectal cancer
Enclavenib combined with cetuximab
-the United States was approved.
Indications approved: FDA approved encorafenib combined with cetuximab in the treatment of metastatic colorectal cancer with BRAF V600E mutation. [3]
Drug effect: BEACON CRC study (NCT02928224) randomly assigned 220 patients to the experimental group treated with enclavini and cetuximab, and randomly assigned 22/kloc-0 patients to the control group treated with irinotecan or FOLFIRI and cetuximab:
Hepatobiliary hepatocellular carcinoma
Pemetrexed (Pemetinib)-Approved by the United States
This is the first targeted therapy for cholangiocarcinoma approved by FDA.
Approved indications: pemigatinib is approved by FDA to treat patients with locally advanced or metastatic cholangiocarcinoma. These patients have been treated before and have FGFR2 fusion or rearrangement, which cannot be surgically removed [4].
Drug effect: FIGHT-202 test (NCT02924376) showed that the ORR was 36% in 107 patients, including 3 patients with complete remission. The median DOR was 9. 1 month, in which 38 patients (63%) had a remission duration of more than 6 months, and 7 patients (18%) had a remission duration of more than 12 months.
lymphoma
Ibrutinib (new indication)-approved in the United States
Indications for approval: The FDA approved the initial treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with ibtinib combined with rituximab [5].
Efficacy: E 19 12 test (NCT020488 13) showed. Compared with the control group (fludarabine, cyclophosphamide combined with rituximab), the PFS of the experimental group (Ibtinib combined with rituximab) was significantly improved (HR=0.34, P < 0.000 1), and the median follow-up time was 37 months. Neither group reached the median PFS.
myeloma
Isatuzumab -irfc(SARCLISA)
Combination of pomadopam and dexamethasone
-the United States was approved.
Approved indications: The FDA approved the combination of isatuximab-irfc with pomadopam and Dexamethasone for adult patients with multiple myeloma who had previously received at least two treatments, including lenalidomide and proteasome inhibitors.
Drug effect: ICARIA-MM study (NCT02990338) showed that the risk of disease progression or death was reduced by 40% (HR = 0.596; ; P = 0.00 10). The median PFS of patients receiving Isa-Pd was 1 1.53 months, while the median PFS of patients receiving pomadumide and low-dose dexamethasone was 6.47 months [6].
Ovarian cancer, fallopian tube cancer or primary peritoneal cancer.
Niraparib (new indication)-approved in the United States
Approved indications: FDA approved niraparib (ZEJULA) for maintenance treatment of adult patients with advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, who fully or partially responded to first-line platinum chemotherapy [7].
From March 2065438 to March 2007, FDA approved the drug for maintenance treatment of female patients with recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. From 20 19 to 10, the drug was approved by FDA for the treatment of advanced ovarian cancer patients who had received more than three kinds of chemotherapy.
Drug effect: PRIMA study (NCT026550 16) showed that PFS benefited niraparib group in homologous recombination deficient population and all populations.
Write it at the end
It is hoped that the listing of new drugs will bring more treatment options to patients and make the anti-cancer work smoother. Have you found all the six "firsts" mentioned at the beginning?
refer to
[1] combination-cetuximab-metastatic colorectal cancer -braf-v600e- mutation
[4] https://www.fda.gov/drugs/resources-information-approved-drugs/FDA-grants-accelerated-approved-pemigitinib-cholangiocarcinoma -fgfr 2- rearrangement -or-fusion.
[5] https://www.fda.gov/drugs/drug-approvals-and-databases/FDA-approvals-ibrutinib-plus-rituximab-chronic lymphocytic leukemia.
[6]http://www . hoparx . org/drug-updates-from-the-FDA/isatuximab-irfc-sarclisa-sanofi-aventis-u-s-LLC
[7] https://www.fda.gov/drugs/drug-approvals-and-databases/FDA-approvals-niraparib-first-line-maintenance-advanced-ovarian cancer.