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According to the latest announcement by the National Medical Products Administration, Bayer’s PI3K inhibitor Copanlisib injection freeze-dried preparation was included in the priority review list on April 14.
The proposed indication is the relapse or refractory that has received at least two systemic treatments in the past.
Treatment of adult patients with follicular lymphoma (FL).
Follicular lymphoma is a mature b-cell lymphoma derived from the follicular germinal center and one of the most common non-Hodgkin’s lymphomas.
It has a low degree of malignancy.
Chemotherapy and radiotherapy have good therapeutic effects on this disease.
.
However, the patient’s condition often recurs after remission.
Therefore, patients suffering from follicular lymphoma need to undergo regular check-ups and monitoring throughout their lives, otherwise this type of disease may turn into malignant lymphoma, which is life-threatening.
Copanlisib is an intravenously injected phosphatidylinositol-3-kinase (PI3K) inhibitor.
It has inhibitory activity on both PI3K-α and PI3K-δ subtypes expressed in malignant B cells.
And inhibit the proliferation of malignant B cells to induce tumor cell death.
Copanlisib molecular structure (picture source: Wikipedia) In September 2017, Copanlisib was approved by the U.
S.
Food and Drug Administration for the treatment of adult patients with recurrent follicular lymphoma who have received at least two systemic therapies.
The accelerated approval of this indication is based on the results of an open-label, single-arm Phase II CHRONOS-1 study.
The overall response rate (ORR) of patients treated with Copanlisib was 59%, of which the CR rate was 14%.
The latest results updated after 2 years of follow-up showed that the ORR of the FL population was 59%, of which the CR rate was 20%.
At the recently opened 2021AACR virtual conference, Bayer announced the results of a phase III clinical trial of Copanlisib and Rituximab in the treatment of relapsed indolent non-Hodgkin's lymphoma (iNHL).
After combined treatment, the risk of disease progression and death of iNHL patients was reduced by 48%, and the median survival time was increased from 13.
8 months to 21.
5 months.
In addition to Bayer’s Copanlisib, which has been declared for listing, there are many PI3K inhibitors in different clinical trials at home and abroad.
Among them, Novartis’s Alpelisib and Buparlisib, Roche’s Taselisib and GDC-0077 are all in the phase III clinical stage.
The products of local Chinese companies such as DaDa, Hutchison Whampoa, and CSPC are currently in phase I/II clinical phases.End reference materials: [1]CDE official website[2]https://mp.
weixin.
qq.
com/s/9iu5eFeE_j5_eABdjnYPvQ Selected onlookers in the past Nature: Subverting a century of cancer metabolism theory! It is not necessarily a good thing that the cancer that consumes glucose crazily is not cancer cells.
The Cell sub-journal reveals that bacteria can promote skin wound healing and hair follicle renewal.
A review of the Cell sub-journal: "starve to death" cancer cells, the approach and challenge of amino acid depletion therapy.
If the cells are aging, check the prostaglandin and the research of the Cell sub-news reveals that if you exercise more during pregnancy and supplement vitamin D, your baby will be healthier! Medical immunotherapy| Biosimilars| Vaccines| Drug resistance| Drug targets| Healthy life| Pharmaceutical company news| Drug inventory| Pharmaceutical technology| Basic research on side effects of drugs/ Translational medicine leukemia| Lung cancer| Gastric cancer| Colorectal cancer| Liver cancer| Breast Cancer | Pancreatic Cancer | Cardiovascular Diseases | Neurodegenerative Diseases | Intestinal Microbial Medical Devices / Biotechnology In Vitro Diagnosis | Medical Devices | Bio-Nano | 3D Printing | Gene Testing | Single Cell Sequencing | Gene Editing | Assisted Reproduction | Artificial Intelligence | Precision medicine policy anti-cancer drugs | 4+7 volume procurement | Consumables | Filing system | Registrant system | Healthy China | New version of the basic medicine catalog | AI medical devices | Telemedicine | Same stock market with different rights / capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | Growth Enterprise Market | R & D Investment | Acquisitions | Market & Consumption
The proposed indication is the relapse or refractory that has received at least two systemic treatments in the past.
Treatment of adult patients with follicular lymphoma (FL).
Follicular lymphoma is a mature b-cell lymphoma derived from the follicular germinal center and one of the most common non-Hodgkin’s lymphomas.
It has a low degree of malignancy.
Chemotherapy and radiotherapy have good therapeutic effects on this disease.
.
However, the patient’s condition often recurs after remission.
Therefore, patients suffering from follicular lymphoma need to undergo regular check-ups and monitoring throughout their lives, otherwise this type of disease may turn into malignant lymphoma, which is life-threatening.
Copanlisib is an intravenously injected phosphatidylinositol-3-kinase (PI3K) inhibitor.
It has inhibitory activity on both PI3K-α and PI3K-δ subtypes expressed in malignant B cells.
And inhibit the proliferation of malignant B cells to induce tumor cell death.
Copanlisib molecular structure (picture source: Wikipedia) In September 2017, Copanlisib was approved by the U.
S.
Food and Drug Administration for the treatment of adult patients with recurrent follicular lymphoma who have received at least two systemic therapies.
The accelerated approval of this indication is based on the results of an open-label, single-arm Phase II CHRONOS-1 study.
The overall response rate (ORR) of patients treated with Copanlisib was 59%, of which the CR rate was 14%.
The latest results updated after 2 years of follow-up showed that the ORR of the FL population was 59%, of which the CR rate was 20%.
At the recently opened 2021AACR virtual conference, Bayer announced the results of a phase III clinical trial of Copanlisib and Rituximab in the treatment of relapsed indolent non-Hodgkin's lymphoma (iNHL).
After combined treatment, the risk of disease progression and death of iNHL patients was reduced by 48%, and the median survival time was increased from 13.
8 months to 21.
5 months.
In addition to Bayer’s Copanlisib, which has been declared for listing, there are many PI3K inhibitors in different clinical trials at home and abroad.
Among them, Novartis’s Alpelisib and Buparlisib, Roche’s Taselisib and GDC-0077 are all in the phase III clinical stage.
The products of local Chinese companies such as DaDa, Hutchison Whampoa, and CSPC are currently in phase I/II clinical phases.End reference materials: [1]CDE official website[2]https://mp.
weixin.
qq.
com/s/9iu5eFeE_j5_eABdjnYPvQ Selected onlookers in the past Nature: Subverting a century of cancer metabolism theory! It is not necessarily a good thing that the cancer that consumes glucose crazily is not cancer cells.
The Cell sub-journal reveals that bacteria can promote skin wound healing and hair follicle renewal.
A review of the Cell sub-journal: "starve to death" cancer cells, the approach and challenge of amino acid depletion therapy.
If the cells are aging, check the prostaglandin and the research of the Cell sub-news reveals that if you exercise more during pregnancy and supplement vitamin D, your baby will be healthier! Medical immunotherapy| Biosimilars| Vaccines| Drug resistance| Drug targets| Healthy life| Pharmaceutical company news| Drug inventory| Pharmaceutical technology| Basic research on side effects of drugs/ Translational medicine leukemia| Lung cancer| Gastric cancer| Colorectal cancer| Liver cancer| Breast Cancer | Pancreatic Cancer | Cardiovascular Diseases | Neurodegenerative Diseases | Intestinal Microbial Medical Devices / Biotechnology In Vitro Diagnosis | Medical Devices | Bio-Nano | 3D Printing | Gene Testing | Single Cell Sequencing | Gene Editing | Assisted Reproduction | Artificial Intelligence | Precision medicine policy anti-cancer drugs | 4+7 volume procurement | Consumables | Filing system | Registrant system | Healthy China | New version of the basic medicine catalog | AI medical devices | Telemedicine | Same stock market with different rights / capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | Growth Enterprise Market | R & D Investment | Acquisitions | Market & Consumption
