-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
To learn more, click [Read the original text] to enter the official website.
The FDA's accelerated approval pathway was established in 1992.
It aims to accelerate the treatment of serious diseases that do not meet clinical needs based on proven alternative or intermediate clinical endpoints that predict clinical benefits.
Approval of the drug.
Drugs that have received accelerated approval need to comply with post-marketing requirements (PMR) to confirm that their clinical benefits can be converted to full approval, otherwise the "accelerated approval" will be revoked.
The application of accelerated approval in the field of oncology far exceeds other therapeutic areas.
In the past ten years, about 85% of accelerated approvals have been granted to this field.
The star drug PD-1/L1 inhibitor for tumor treatment is undoubtedly the biggest of this policy.
Beneficiaries, since 2015, the accelerated approval of PD-1/L1 drugs accounted for half of the accelerated approval of cancer drugs.
However, these PD-1s that have received accelerated approval for marketing cannot always verify their clinical benefits.
The FDA discovered in the accelerated review of the entire industry that 10 other indications that failed to verify their clinical benefits in confirmatory trials are still on the market.
Previously, after consultations with the FDA, the four drugmakers have each voluntarily withdrew an indication of their PD-1/L1 drugs (Roche-Tecentriq, Merck-Keytruda, Bristol-Myers Squibb-Opdivo, AstraZeneca) --Imfinzi).
But there are six indications that are "unresolved" making it difficult for the FDA to make a decision.
The FDA cannot unilaterally withdraw accelerated approval drugs from the market.
According to the accelerated approval regulatory procedures, if the sponsor does not agree with the FDA’s additional clinical research requirements or withdrawal of indications, a public hearing can be sought, and this withdrawal The process is extremely time-consuming and cumbersome.Therefore, in the middle of last month, the FDA called on the Oncology Drug Advisory Expert Committee (ODAC) to intervene to discuss the issue of the retention of the remaining six indications that passed the accelerated approval for marketing but failed to meet the post-marketing requirements.
Yesterday (April 27, 2021), the results of Roche Tecentriq's first-line treatment of triple-negative breast cancer were announced.
The Oncology Drug Advisory Committee (ODAC) voted 7:2 (for: against) to support the approval to stay in the market.
Based on data from a clinical study called IMpassion130, in March 2019, the FDA accelerated the approval of Tecentriq combined with Abraxane (albumin paclitaxel) for the first-line treatment of PD-L1-positive advanced or metastatic triple-negative breast cancer patients, which is also used The first immunotherapy for breast cancer treatment.
However, the clinical trial IMpassion131 used to verify the clinical benefits of the combination therapy failed.
The results of the clinical study showed that the Tecentriq+paclitaxel group not only failed to defeat paclitaxel alone, but in the progression-free survival (PFS) and overall survival (OS) ) Are inferior to the paclitaxel single-drug group, which aroused the FDA’s concern.
On September 8, 2020, a warning letter was issued to warn clinicians not to use paclitaxel instead of Abraxane when prescribing.
Roche has carried out three phase III clinical studies of Tecentriq in TNBC, but the FDA still does not know which of these trials have fully confirmed the clinical benefits of Tecentriq.
In the end, even though the FDA had doubts about the clinical benefit of Tecentriq in mTNBC, it did not completely give up, and assisted Roche in completing follow-up clinical trials to verify its clinical benefit in patients with high PD-L1 expression in mTNBC.
Previously, Roche had voluntarily withdrawn one of Tecentriq's indications-second-line treatment for patients with urothelial cancer.
In May 2016, Tecentriq was approved by the FDA for the second-line treatment of patients with locally advanced or metastatic urothelial cancer, becoming the first PD-L1 inhibitor approved by the FDA.
But one year after Tecentriq received accelerated approval, the label's verification test IMvigor211 failed.
In addition, in the first-line label validation trial IMvigor130 for this indication, it was found that patients with low PD-L1 expression experienced a decline in survival rate after receiving Tecentriq monotherapy.
For this reason, the FDA has made a report on the populations suitable for the Tecentriq label.
PD-L1 positive expression restriction.
At present, the status of this indication will be determined after today's expert discussion.
Reference source 1.
https://endpts.
com/tech-glitches-overshadow-fda-oncology-adcomm-as-a-solid-majority-of-advisers-vote-to-pull-roches-tecentriq-in-mtnbc/ 2.
#:~:text =On%20September%208%2C%202020%2C%20the,or%20metastatic%20triple%20negative%20breast The copyright statement welcomes personal forwarding and sharing.
Any other media or website that needs to reprint or quote the copyrighted content of this website must be authorized and marked "Reprinted from: Bai Aogu" in a prominent position.
The FDA's accelerated approval pathway was established in 1992.
It aims to accelerate the treatment of serious diseases that do not meet clinical needs based on proven alternative or intermediate clinical endpoints that predict clinical benefits.
Approval of the drug.
Drugs that have received accelerated approval need to comply with post-marketing requirements (PMR) to confirm that their clinical benefits can be converted to full approval, otherwise the "accelerated approval" will be revoked.
The application of accelerated approval in the field of oncology far exceeds other therapeutic areas.
In the past ten years, about 85% of accelerated approvals have been granted to this field.
The star drug PD-1/L1 inhibitor for tumor treatment is undoubtedly the biggest of this policy.
Beneficiaries, since 2015, the accelerated approval of PD-1/L1 drugs accounted for half of the accelerated approval of cancer drugs.
However, these PD-1s that have received accelerated approval for marketing cannot always verify their clinical benefits.
The FDA discovered in the accelerated review of the entire industry that 10 other indications that failed to verify their clinical benefits in confirmatory trials are still on the market.
Previously, after consultations with the FDA, the four drugmakers have each voluntarily withdrew an indication of their PD-1/L1 drugs (Roche-Tecentriq, Merck-Keytruda, Bristol-Myers Squibb-Opdivo, AstraZeneca) --Imfinzi).
But there are six indications that are "unresolved" making it difficult for the FDA to make a decision.
The FDA cannot unilaterally withdraw accelerated approval drugs from the market.
According to the accelerated approval regulatory procedures, if the sponsor does not agree with the FDA’s additional clinical research requirements or withdrawal of indications, a public hearing can be sought, and this withdrawal The process is extremely time-consuming and cumbersome.Therefore, in the middle of last month, the FDA called on the Oncology Drug Advisory Expert Committee (ODAC) to intervene to discuss the issue of the retention of the remaining six indications that passed the accelerated approval for marketing but failed to meet the post-marketing requirements.
Yesterday (April 27, 2021), the results of Roche Tecentriq's first-line treatment of triple-negative breast cancer were announced.
The Oncology Drug Advisory Committee (ODAC) voted 7:2 (for: against) to support the approval to stay in the market.
Based on data from a clinical study called IMpassion130, in March 2019, the FDA accelerated the approval of Tecentriq combined with Abraxane (albumin paclitaxel) for the first-line treatment of PD-L1-positive advanced or metastatic triple-negative breast cancer patients, which is also used The first immunotherapy for breast cancer treatment.
However, the clinical trial IMpassion131 used to verify the clinical benefits of the combination therapy failed.
The results of the clinical study showed that the Tecentriq+paclitaxel group not only failed to defeat paclitaxel alone, but in the progression-free survival (PFS) and overall survival (OS) ) Are inferior to the paclitaxel single-drug group, which aroused the FDA’s concern.
On September 8, 2020, a warning letter was issued to warn clinicians not to use paclitaxel instead of Abraxane when prescribing.
Roche has carried out three phase III clinical studies of Tecentriq in TNBC, but the FDA still does not know which of these trials have fully confirmed the clinical benefits of Tecentriq.
In the end, even though the FDA had doubts about the clinical benefit of Tecentriq in mTNBC, it did not completely give up, and assisted Roche in completing follow-up clinical trials to verify its clinical benefit in patients with high PD-L1 expression in mTNBC.
Previously, Roche had voluntarily withdrawn one of Tecentriq's indications-second-line treatment for patients with urothelial cancer.
In May 2016, Tecentriq was approved by the FDA for the second-line treatment of patients with locally advanced or metastatic urothelial cancer, becoming the first PD-L1 inhibitor approved by the FDA.
But one year after Tecentriq received accelerated approval, the label's verification test IMvigor211 failed.
In addition, in the first-line label validation trial IMvigor130 for this indication, it was found that patients with low PD-L1 expression experienced a decline in survival rate after receiving Tecentriq monotherapy.
For this reason, the FDA has made a report on the populations suitable for the Tecentriq label.
PD-L1 positive expression restriction.
At present, the status of this indication will be determined after today's expert discussion.
Reference source 1.
https://endpts.
com/tech-glitches-overshadow-fda-oncology-adcomm-as-a-solid-majority-of-advisers-vote-to-pull-roches-tecentriq-in-mtnbc/ 2.
#:~:text =On%20September%208%2C%202020%2C%20the,or%20metastatic%20triple%20negative%20breast The copyright statement welcomes personal forwarding and sharing.
Any other media or website that needs to reprint or quote the copyrighted content of this website must be authorized and marked "Reprinted from: Bai Aogu" in a prominent position.
