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January 4, 2022/eMedClub PR News/--Recently, according to the official website of the Center for Drug Evaluation (CDE) of the State Drug Administration, Roche has declared four "Vibtuzumab" Listing application
.
Polatuzumab vedotin is a "first-in-class" antibody-conjugated drug (ADC) targeting CD79b.
It is mainly used to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
)
.
▲ Image source: CDE official website DLBCL is the most common non-Hodgkin lymphoma (NHL), accounting for about one-third of NHL cases, and DLBCL is an aggressive (rapidly growing) type of NHL
.
Although the disease usually has some effect on first-line treatment, as many as 40% of patients will relapse.
At this time, rescue treatment options are limited and the survival period is short
.
It is estimated that about 150,000 people worldwide are diagnosed with DLBCL every year
.
Vibotuzumab targets B cell antigen receptor complex-related protein β chain (CD79b), and then specifically binds to CD79b in tumor cells to release toxin molecules into tumor cells, thereby killing tumor cells.
At the same time, the drug can also reduce damage to normal cells
.
In June 2019, Vibotuzumab was approved by the U.
S.
FDA for use in combination with bendamustine and rituximab for relapsed or refractory diffuse large B-cell lymphoma, under the trade name POLIVY
.
In China, CDE successively accepted Roche's four marketing applications for vembrolizumab for injection in December 2021
.
On December 21, 2021, CDE included Vibotuzumab in the proposed priority review for the treatment of adult patients with relapsed or refractory diffuse large B lymphoma (DLBCL)
.
On December 14, 2021, Roche issued a press release of Vibotuzumab and R-CHP (Rituximab + Cyclophosphamide + Doxorubicin + Prednisone).
Compared with the standard of treatment R-CHOP (rituximab + cyclophosphamide + doxorubicin + vincristine + prednisone) in the treatment of relapsed or refractory diffuse large B lymphoma (DLBCL) adults The risk in patients is significantly reduced by 27%, so the combined program may benefit more patients
.
ADC track fiery antibody-drug conjugates (ADC drugs) are a new type of targeted drugs composed of monoclonal antibodies, cytotoxic drugs, and linkers that connect the two
.
Its original intention is to improve the effectiveness of chemotherapy and reduce its toxicity
.
Because antibodies are targeted (recognizing the surface antigens of cancer cells), they can selectively "transport" cytotoxic molecules directly to tumor cells, exerting an anti-cancer effect while avoiding impact on healthy cells
.
In recent years, ADC has gradually become a new trend in the development of anti-tumor drugs
.
ADC drugs fill the gap between antibody drugs and traditional chemotherapy drugs, improve the specificity of drugs and improve the treatment window
.
At present, the ADC therapy, the most fiery of the main targets CD19, CD33, CD30, HER2, CD22, FRα, Nectin-4, HER2, BCMA, Her2, TF and so on
.
On December 22, 2021, the latest announcement of the National Medical Products Administration (NMPA) of China showed that Pfizer's application for ogaituzumab for injection (Besponsa, formerly known as: inotuzumab for injection) Zolmicin) has been approved in China
.
Besponsa is an antibody-conjugated drug (ADC) targeting CD22.
The approved indication is adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL)
.
Recommended reading: Heavy! For the treatment of leukemia, Pfizer's new ADC therapy was approved for the market in ChinaYimai Meng broke the news.
On December 17, 2021, Astellas Pharma and Seagen announced that the ADC drug PADCEV™ (enfortumab vedotin) jointly developed by them has been obtained Active support of EMA’s Committee on Medicinal Products for Human Use (CHMP)
.
Enfortumab vedotin is a "first-in-class" ADC drug product that targets the cell surface protein Nectin-4
.
The drug consists of the human IgG1 monoclonal antibody enfortumab targeting Nectin-4 conjugated with the cytotoxic agent MMAE
.
Recommended reading: Looking forward to the multi-party listing, Astellas's ADC drug targeting Nectin-4 has regained support from the European UnionYi Mai Meng broke the news in December 2021, CytomX Therapeutics announced CX-2029 for the treatment of advanced squamous non-small cell lung cancer (sqNSCLC) ) Or preliminary results of a phase 2 clinical trial in patients with head and neck squamous cell carcinoma (HNSCC)
.
CX-2029, jointly developed by CytomX and AbbVie, is a conditionally activated antibody-drug conjugate (ADC), which is inhibited by a humanized monoclonal antibody targeting the transferrin receptor CD71 and microtubules The monomethyl MMAE is conjugated through a cleavable linker, and the drug-to-antibody ratio (DAR) is 2
.
Recommended reading: Targeting CD71, the latest clinical data of ADC drug co-developed by AbbVie Yimai Meng broke the news In November 2021, Immunogen, which focuses on the development of ADC antibody conjugate drugs, announced its FRα-targeted ADC new drug Mirvetuximab Soravtansine In the treatment of ovarian cancer registered clinical SORAYA reached the primary endpoint, ImmunoGen plans to apply for FDA approval in the first quarter of 2022 based on existing data
.
Recommended reading: The first FRα target ADC drug has obtained key clinical data, and will submit a marketing application next year.
Yimai Meng broke the news.
Reference materials: 1.
https:// -2021-12-14.
htm2.
"Roche's "first-in-class" ADC therapy application for listing in China" Statement by Guanlan Pharmaceuticals: The content in this article is only used to explore the frontier progress of biomedicine and does not constitute any medical guidance, if required Please go to a regular hospital for treatment
.