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PD-(L)1 starts the wave of indication withdrawal, who is the next target?

 Last Update: 2021-04-27
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Several kinds of 5px;font-family:mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">PD-(L)15px;font-family:mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">Although multiple indications of anti-cancer drugs have been approved for marketing through the FDA's accelerated approval program for several years, post-marketing confirmatory trials have failed to confirm the early test results.
Although industry insiders continue to call on the agency not to compromise its regulatory standards, the FDA has not previously taken corresponding actions on these failed studies.
Although multiple indications of anti-cancer drugs have been approved for marketing through the FDA's accelerated approval program for several years, post-marketing confirmatory trials have failed to confirm the early test results.
Although industry insiders continue to call on the agency not to compromise its regulatory standards, the FDA has not previously taken corresponding actions on these failed studies.

544px;text-align:justify;white-space:normal;background-color:#FFFFFF;box-sizing:border-box ;overflow-wrap:break-word ;'>

However, until recently, drugmakers suddenly began to accelerate the withdrawal of their PD-(L)1 immuno-oncology therapy indications after failing confirmatory trials .

As a regulatory agency, the FDA has also begun to take the initiative to take action!

Review: 4 consecutive withdrawals

5px solid #111122;border-top-color:#111122;border-right-color:#111122;border-left-color:#111122;">1Keytruda/Keytruda

On March 8, Roche announced that the company voluntarily withdrew its PD-L1 antibody Tecentriq/Tecentriq (atezizumab) for use in the United States for metastatic urothelial carcinoma (mUC) previously treated with platinum after consulting with the FDA.

, Bladder cancer) indications.

According to the results of the IMvigor210 study (Cohort 2), Teshanqi received accelerated approval in 2016 for the treatment of metastatic urothelial cancer previously treated with platinum.

5px solid #111122;border-top-color:#111122;border-right-color:#111122;border-left-color:#111122;">2Keytruda

3 Yue 1 day Merck announced that the company voluntarily withdrew its PD-15px;">monoclonal antibody5px;">Can Investor / Keytruda ( Pabo Li daclizumab ) in the United States for the treatment of other received progressed after previous treatment of metastatic disease line platinum-based chemotherapy in small cell lung cancer or at least one (SCLC) eligible patients.
The withdrawal of this indication was completed in consultation with the FDA , and Merck is working hard to complete this procedure in the next few weeks.
This decision will not affect Kerida's other indications.

According to KEYNOTE-158 (cohort G) and KEYNOTE-028 (cohortC1) studies on tumor remission rate and response durability data, Kerida received accelerated approval from the FDA in June 2019 .
The full approval of this indication depends on the results of the confirmatory test of the overall survival (OS) of the drug after marketing .
In January 2020 , the confirmatory phase III trial KEYNOTE-604 for this indication reached one of its combined primary endpoints, namely progression-free survival, but the other primary endpoint, overall survival, did not reach statistical significance.

5px solid #111122;border-top-color:#111122;border-right-color:#111122;border-left-color:#111122;">3Imfinzi

2 Yue 22 days, AstraZeneca announced a voluntary withdrawal of its US PD-L1 monoclonal antibody Britain - Where / Imfinzi ( degree cutting Li You mAbs ) for the treatment of previously treated locally advanced or metastatic bladder cancer in adult patients adapt disease.
The decision was made after consultation with the FDA .

2017 Nian 5 months, the British-Where an assessment for advanced solid tumors ( including previously treated bladder cancer ) the safety and efficacy of the5px;"> I / II5px;">In the Phase Study 1108 trial study, good tumor remission rate and response duration data were obtained, and then accelerated FDA approval was obtained.
The full approval of this indication depends on the results of Infineon 's Phase III DANUBE trial in the treatment of first-line metastatic bladder cancer , which did not meet its primary endpoint in 2020 .

5px solid #111122;border-top-color:#111122;border-right-color:#111122;border-left-color:#111122;">4Opdivo

2020 Nian 12 Yue 29 days, Bristol-Myers Squibb announced by the FDA consultation, decided to withdraw it from the US market PD-1 monoclonal antibody Oudi Wo / Opdivo ( Carolina Wu Li You mAb ) for the treatment received platinum-based chemotherapy or At least one other indication for patients with metastatic small cell lung cancer whose disease has progressed after the previous treatment line .

In 2018 , based on Odivo’s Phase I/II CheckMate -032 study for patients with advanced or metastatic solid tumors as an alternative endpoint , it obtained accelerated approval from the FDA .
This trial showed that in small cell lung cancer, the response rate and duration of response using Odivo were encouraging.
However, subsequent confirmatory studies (CheckMate-451 and CheckMate-331) in different treatment settings did not reach their primary endpoint of overall survival.

With the accelerated approval of drug indications that may encounter setbacks in post-marketing confirmatory trials and studies, it is inevitable to withdraw the indications.

Outlook: Who will be the next indication withdrawal?

For example, Merck’s Kerida obtained accelerated FDA approval in November 2018 based on the tumor reduction data in the Phase II Keynote-224 trial for use in the treatment of previously targeted drugs Bayer’s Nexavar /Nexavar ( Sorafenib ) .
Patients with hepatocellular carcinoma (HCC) .
The 2019 Nian 6 month of publication III of Keynote-240 clinical trials, the Investor may treat patients although the disease did not worsen, but it did not prolong life or prolong the survival time of patients.

In June 2019 , Bristol-Myers Squibb’s Odivo encountered a similar setback in the CheckMate-459 trial for liver cancer indications .
The indications of Odivo for hepatocellular carcinoma patients who have previously been treated with the targeted drug NEXAVAR received accelerated FDA approval in 2017 .
The results of the Phase III CheckMate -459 study evaluating Odivo for the first-line treatment of patients with unresectable hepatocellular carcinoma showed that the primary endpoint of the trial's overall survival was not statistically significant.
Although CheckMate-459 has not yet reached its pre-specified primary endpoint, the results show that compared with the current standard of treatment sorafenib, the overall survival of patients treated with Odivo has a clear trend of improvement.

Affected by this, in January 2020 , in the third update of the European Society of Medical Oncology (ESMO) " 2019 Hepatocellular Carcinoma Clinical Practice Guidelines" , Odivo and Kerida were deleted .
The reasons are: Odivo’s The clinical trial CheckMate-459 ( Phase III ) failed, Odivo vs Sorafenib did not bring significant overall survival benefit to patients with hepatocellular carcinoma.
Kerida as a second-line program compared to placebo plus the best supportive treatment KEYNOTE-240 ( Phase III ) study failed to achieve the common primary endpoint of overall survival and progression-free survival (PFS) , and it is still necessary to wait for the final results of the randomized trial And more mature follow-up data.

Kerida's indications also include 3- line therapy for adenocarcinoma of the stomach or gastroesophageal junction .
The drug stumbled in the Keynote-061 and Keynote-062 trials of previously treated patients and first-line patients, respectively .
The failures of these two studies were recorded in 2017 and 2019 , respectively.
Although they occurred before the failure of the small cell lung cancer confirmatory trial, the three- line conditional accelerated approval indications still exist.

In addition, 2020 Nian 6 Yue 9 days, Merck announced a program called KEYNOTE-361 of III results of clinical trials.
This study aims to evaluate the efficacy of Corrida combined with chemotherapy in the first-line treatment of advanced or metastatic urothelial carcinoma (UC) .
The results show that compared with standard chemotherapy, Corrida combined with chemotherapy did not achieve overall survival and progression-free survival.
The dual primary endpoint.

So far, it is not clear what specific criteria the FDA used when persuading these companies to withdraw the indications for which their confirmatory trials failed.

As early as in 2017 , despite Roche 's especially good odd / Tecentriq ( Art trastuzumab ) after accelerated approval III of IMvigor211 clinical studies in previously treated locally advanced disease progression during or after chemotherapy with platinum-based chemotherapy or metastatic urothelial Data in patients with cancer (mUC) showed that compared with chemotherapy, Teshanqi did not achieve the primary endpoint of improving overall survival, but the safety was consistent with previous data.
In spite of this, the indications of Teshanqi for bladder cancer patients who have not received previous treatment ( first-line treatment ) and are not suitable for cisplatin-based chemotherapy are still allowed by the FDA to retain.
Despite the subsequentFDAwillIMvigor130study specified as a listing requirements, however, with the rapid emergence of new treatment options previously treated with platinum-based therapy (second-line) metastatic urothelial cancer (eg,2020Nian07months, Merck/PfizerPD- L1therapyBavencio(avelumab) obtainedFDAApproved for the maintenance treatment of patients with locally advanced or metastatic urothelial cancer who have not progressed on first-line platinum-containing chemotherapy), Roche eventually withdrew the indication voluntarily.

Although the current four PD-(L)1 indications withdrawal incidents were voluntarily withdrawn after consultation between the company and the FDA, the regulatory agency will undoubtedly be subject to more and more doubts and disputes, and it may be possible to implement accelerated approval in the future.
Be more cautious.
For other anti-PD-(L)1 drug developers, it may only become more and more difficult to pass accelerated approval in the future to market in advance.

Review: 4 consecutive withdrawals

5px solid #111122;border-top-color:#111122;border-right-color:#111122;border-left-color:#111122;">1Keytruda/Keytruda

, Bladder cancer) indications.

According to the results of the IMvigor210 study (Cohort 2), Teshanqi received accelerated approval in 2016 for the treatment of metastatic urothelial cancer previously treated with platinum.
The full approval of this indication depends on the results of the IMvigor211 study, which is the regulatory agency’s post-marketing requirement (PMR) for the indication of metastatic urothelial cancer previously treated with platinum.
The study did not reach its primary endpoint of overall survival (OS) in a population of patients with high PD-L1.
Subsequently, the FDA designated the IMvigor130 study as a post-marketing requirement, and the study will continue until the final analysis.
However, with the rapid emergence of new treatment options for the treatment of metastatic urothelial carcinoma with platinum (second-line), Roche voluntarily withdrew this indication.

5px solid #111122;border-top-color:#111122;border-right-color:#111122;border-left-color:#111122;">2Keytruda

5px solid #111122;border-top-color:#111122;border-right-color:#111122;border-left-color:#111122;">3Imfinzi

5px solid #111122;border-top-color:#111122;border-right-color:#111122;border-left-color:#111122;">4Opdivo

With the accelerated approval of drug indications that may encounter setbacks in post-marketing confirmatory trials and studies, it is inevitable to withdraw the indications.

Outlook: Who will be the next indication withdrawal?

So far, it is not clear what specific criteria the FDA used when persuading these companies to withdraw the indications for which their confirmatory trials failed.

However, until recently, drugmakers suddenly began to accelerate the withdrawal of their PD-(L)1 immuno-oncology therapy indications after failing confirmatory trials .
As a regulatory agency, the FDA has also begun to take the initiative to take action! However, until recently, drugmakers suddenly began to accelerate the withdrawal of their PD-(L)1 immuno-oncology therapy indications after failing confirmatory trials .
As a regulatory agency, the FDA has also begun to take the initiative to take action!

Review: 4 consecutive withdrawals
Review: 4 consecutive withdrawals
Review: 4 consecutive withdrawalsReview: 4 consecutive withdrawals

5px solid #111122;border-top-color:#111122;border-right-color:#111122;border-left-color:#111122;">1Keytruda/Keytruda5px solid #111122;border-top-color:#111122;border-right-color:#111122;border-left-color:#111122;">1Keytruda/Keytruda1Keytruda/Keytruda1Keytruda/Keytruda

, Bladder cancer) indications.

According to the results of the IMvigor210 study (Cohort 2), Teshanqi received accelerated approval in 2016 for the treatment of metastatic urothelial cancer previously treated with platinum.

The full approval of this indication depends on the results of the IMvigor211 study, which is the regulatory agency’s post-marketing requirement (PMR) for the indication of metastatic urothelial cancer previously treated with platinum.
The study did not reach its primary endpoint of overall survival (OS) in a population of patients with high PD-L1.

According to the results of the IMvigor210 study (Cohort 2), Teshanqi received accelerated approval in 2016 for the treatment of metastatic urothelial cancer previously treated with platinum.

5px solid #111122;border-top-color:#111122;border-right-color:#111122;border-left-color:#111122;">2Keytruda5px solid #111122;border-top-color:#111122;border-right-color:#111122;border-left-color:#111122;">2Keytruda2Keytruda2Keytruda

3 Yue 1 day Merck announced that the company voluntarily withdrew its 3 Yue 1 day 3Yue1dayMerck announced that the company voluntarily withdrew itsPD-15px;">monoclonal antibody5px;">Can Investor / Keytruda ( Pabo Li daclizumab ) in the United States for the treatment of platinum-based chemotherapy had received at least one prior therapy progression, or after other line metastatic small cell lung diseases may Investor / Keytruda ( Pabo Li daclizumab ) in the United States can be Investor/ Keytruda (Pabo Li daclizumab)in the United Statesfor the treatment of platinum-based chemotherapy or had received at least one line after the other prior treatment of metastatic disease progression small cell lung cancer (SCLC) eligible patients.
The withdrawal of this indication was completed in consultation with the FDA , and Merck is working hard to complete this procedure in the next few weeks.
This decision will not affect Kerida's other indications.
(SCLC)Indications for patients.
The withdrawal of this indication wascompleted in consultationwith theFDA, and Merck is working hard to complete this procedure in the next few weeks.
This decision will not affect Kerida's other indications.

KEYNOTE-158(cohort G)KEYNOTE-028(cohortC1)，20196FDA。KEYNOTE-158(cohort G)KEYNOTE-028(cohortC1)，20196FDA。KEYNOTE-158(cohort G)KEYNOTE-028(cohortC1)，20196FDA。(OS)。20201，IIIKEYNOTE-604，，。(OS)。20201，IIIKEYNOTE-604，，。5px solid #111122;border-top-color:#111122;border-right-color:#111122;border-left-color:#111122;">3/Imfinzi5px solid #111122;border-top-color:#111122;border-right-color:#111122;border-left-color:#111122;">3/Imfinzi3/Imfinzi3/Imfinzi

222，，PD-L1/Imfinzi()。FDA。

222，，PD-L1222，222，，PD-L1PD-L1/Imfinzi()。FDA。/Imfinzi()。FDA。

20175，()5px;">I/II5px;">Study 1108，，FDA。IIIDANUBE，2020。

20175，20175，20175，()()5px;">I/II5px;">In the Phase Study 1108 trial study, good tumor remission rate and response duration data were obtained, and then accelerated FDA approval was obtained.
The full approval of this indication depends on the results of Infineon 's Phase III DANUBE trial in the treatment of first-line metastatic bladder cancer , which did not meet its primary endpoint in 2020 .
In the Phase Study 1108 trial study, good tumor remission rate and response duration data were obtained, and then accelerated FDA approval was obtained.
The full approval of this indication depends on the results of Infineon 's Phase III DANUBE trial in the treatment of first-line metastatic bladder cancer , which did not meet its primary endpoint in 2020 .
5px solid #111122;border-top-color:#111122;border-right-color:#111122;border-left-color:#111122;">4Opdivo5px solid #111122;border-top-color:#111122;border-right-color:#111122;border-left-color:#111122;">4Opdivo4Opdivo4Opdivo

20201229，，FDA，PD-1/Opdivo()。20201229，，FDA，PD-120201229，，FDA，PD-1/Opdivo()/Opdivo()。

2018，I/IICheckMate -032，FDA。，，。，(CheckMate -451CheckMate -331)。

2018，2018，2018，I/IICheckMate -032，FDA。，，。，(CheckMate -451CheckMate -331)。I/IICheckMate -032，FDA。，，。，(CheckMate -451CheckMate -331)。

，。

，。：？
：？
：？：？

In less than 3 months, after 3 consecutive withdrawals of PD-(L)1 indications, other projects in this field that failed to achieve satisfactory results in later confirmatory trials through accelerated approval may face the same danger.
In less than 3 months, after 3 consecutive withdrawals of PD-(L)1 indications, other projects in this field that failed to achieve satisfactory results in later confirmatory trials through accelerated approval may face the same danger.

，201811IIKeynote-224，201811IIKeynote-224，201811IIKeynote-224FDA，/Nexavar()(HCC)。20196IIIKeynote-240，，。FDA，/Nexavar()(HCC)。20196IIIKeynote-240，，。

20196，CheckMate-459。2017FDA。IIICheckMate -459，。CheckMate -459，，，。

20196，CheckMate-459。2017FDA。IIICheckMate -459，。20196，20196，CheckMate-459。CheckMate-459。2017FDA。2017FDA。IIICheckMate -459，IIICheckMate -459，。CheckMate -459，，，。CheckMate -459，，，。

，20201，(ESMO)《2019》3，：CheckMate-459(III)，。 KEYNOTE-240(III)(PFS)，。

，20201，(ESMO)《2019》3，：CheckMate-459(III)，。，20201，(ESMO)《2019》3，20201，(ESMO)《2019》3，：CheckMate-459(III)，。CheckMate-459(III)，。 KEYNOTE-240(III)(PFS)，。 KEYNOTE-240(III)(PFS)，。

3。Keynote-061Keynote-062。20172019，，3。

3。Keynote-061Keynote-062。20172019，，3。3。Keynote-061Keynote-062。20172019，，3。

，202069，KEYNOTE-361III。(UC)，，，。

，202069，KEYNOTE-361III。(UC)，，，。，202069，KEYNOTE-361III。(UC)，，，。

，FDA。

，FDA。，FDA。

2017，/Tecentriq()IIIIMvigor211(mUC)，，，。，()FDA。FDAIMvigor130，，（）（，202007，/PD-L1Bavencio（avelumab）FDA），。

2017，2017，2017，/Tecentriq()IIIIMvigor211(mUC)，，，。，()FDA。/Tecentriq()IIIIMvigor211(mUC)，，，。，()FDA。FDAIMvigor130，，（）（，202007，/PD-L1Bavencio（avelumab）FDA），。

4PD-(L)1FDA，，。PD-（L）1，。

4PD-(L)1FDA，，。PD-（L）1，。4PD-(L)1FDA，，。PD-（L）1，。

544px;white-space:normal;background-color:#FFFFFF;text-align:center;box-sizing:border-box ;'>

544px;text-align:justify;white-space:normal;background-color:#FFFFFF;box-sizing:border-box ;overflow-wrap:break-word ;'>：FDA：FDA：FDA：FDA

544px;white-space:normal;background-color:#FFFFFF;text-indent:32px;line-height:2em;box-sizing:border-box ;'> ，FDA 4 27 29 （ODAC）， PD-（L）1 ，。PD-（L）1 6。

，FDA 4 27 29 （ODAC）， PD-（L）1 ，。PD-（L）1 6。，FDA 4 27 29 （ODAC）， PD-（L）1 ，。PD-（L）1 6。

544px;white-space:normal;background-color:#FFFFFF;text-indent:32px;line-height:2em;box-sizing:border-box ;'> TecentriqPD-L1≥1%（TNBC）（427）。

TecentriqPD-L1≥1%（TNBC）（427）。TecentriqPD-L1≥1%（TNBC）（427）。

544px;white-space:normal;background-color:#FFFFFF;text-indent:32px;line-height:2em;box-sizing:border-box ;'> Keytruda（428）。

Keytruda（428）。Keytruda（428）。

544px;white-space:normal;background-color:#FFFFFF;text-indent:32px;line-height:2em;box-sizing:border-box ;'> Tecentriq（428）。

Tecentriq（428）。Tecentriq（428）。

544px;white-space:normal;background-color:#FFFFFF;text-indent:32px;line-height:2em;box-sizing:border-box ;'> Keytruda-，HER2/neu（）（GEJ），PD-L1 [（CPS）≥1] （429）。

Keytruda-，HER2/neu（）（GEJ），PD-L1 [（CPS）≥1] （429）。Keytruda-，HER2/neu（）（GEJ），PD-L1 [（CPS）≥1] （429）。

544px;white-space:normal;background-color:#FFFFFF;text-indent:32px;line-height:2em;box-sizing:border-box ;'> Keytruda（HCC）（429）。

Keytruda（HCC）（429）。Keytruda（HCC）（429）。

544px;white-space:normal;background-color:#FFFFFF;text-indent:32px;line-height:2em;box-sizing:border-box ;'> Opdivo，（HCC）（429）。

Opdivo，（HCC）（429）。Opdivo，（HCC）（429）。

544px;white-space:normal;background-color:#FFFFFF;text-indent:32px;line-height:2em;box-sizing:border-box ;'> ，PD-（L）1 。

，PD-（L）1 。，PD-（L）1 。544px;text-align:justify;white-space:normal;background-color:#FFFFFF;box-sizing:border-box ;overflow-wrap:break-word ;'>8em;max-width:100%;box-sizing:border-box ;overflow-wrap:break-word ;font-size:16px;letter-spacing:1.
5px;color:#822F0B;font-weight:bold;border-width:1px;border-style:solid;border-color:#822F0B;border-radius:30px;background-image:initial;background-position:initial;background-size:initial;background-repeat:initial;background-attachment:initial;background-origin:initial;background-clip:initial;">：PD-(L)18em;max-width:100%;box-sizing:border-box ;overflow-wrap:break-word ;font-size:16px;letter-spacing:1.
5px;color:#822F0B;font-weight:bold;border-width:1px;border-style:solid;border-color:#822F0B;border-radius:30px;background-image:initial;background-position:initial;background-size:initial;background-repeat:initial;background-attachment:initial;background-origin:initial;background-clip:initial;">：PD-(L)18em;max-width:100%;box-sizing:border-box ;overflow-wrap:break-word ;font-size:16px;letter-spacing:1.
5px;color:#822F0B;font-weight:bold;border-width:1px;border-style:solid;border-color:#822F0B;border-radius:30px;background-image:initial;background-position:initial;background-size:initial;background-repeat:initial;background-attachment:initial;background-origin:initial;background-clip:initial;">：PD-(L)18em;max-width:100%;box-sizing:border-box ;overflow-wrap:break-word ;font-size:16px;letter-spacing:1.
5px;color:#822F0B;font-weight:bold;border-width:1px;border-style:solid;border-color:#822F0B;border-radius:30px;background-image:initial;background-position:initial;background-size:initial;background-repeat:initial;background-attachment:initial;background-origin:initial;background-clip:initial;">：PD-(L)1PD-(L)1

544px;text-align:justify;white-space:normal;background-color:#FFFFFF;text-indent:32px;line-height:2em;box-sizing:border-box ;'> 2010，FDA130，，82％。

2010，FDA130，，82％。

544px;text-align:justify;white-space:normal;background-color:#FFFFFF;text-indent:32px;line-height:2em;box-sizing:border-box ;'> PD-(L)1，。

PD-(L)1，。

544px;text-align:justify;white-space:normal;background-color:#FFFFFF;text-indent:32px;line-height:2em;box-sizing:border-box ;'> FDA，11（2010-2020），18，。，：Keytruda。2010，Keytruda14％。

FDA，11（2010-2020），18，。，：Keytruda。2010，Keytruda14％。

544px;text-align:justify;white-space:normal;background-color:#FFFFFF;text-indent:32px;line-height:2em;box-sizing:border-box ;'> ，，。，。

，，。，。

544px;text-align:justify;white-space:normal;background-color:#FFFFFF;text-indent:32px;line-height:2em;box-sizing:border-box ;'> Opdivo11，Keytruda18。Opdivo3，2016。

Opdivo11，Keytruda18。Opdivo3，2016。

544px;text-align:justify;white-space:normal;background-color:#FFFFFF;text-indent:32px;line-height:2em;box-sizing:border-box ;'> Opdivo，Yervoy，Sprycel（）PomalystIstodax。

Opdivo，Yervoy，Sprycel（）PomalystIstodax。

544px;text-align:justify;white-space:normal;background-color:#FFFFFF;text-indent:32px;line-height:2em;box-sizing:border-box ;'> ，Alecensa，Perjeta，Polivy，Rozlytrek，Tecentriq（）Gavreto（）；。

，Alecensa，Perjeta，Polivy，Rozlytrek，Tecentriq（）Gavreto（）；。

544px;white-space:normal;background-color:#FFFFFF;text-align:center;box-sizing:border-box ;'>

544px;text-align:justify;white-space:normal;background-color:#FFFFFF;text-indent:32px;line-height:2em;box-sizing:border-box ;'> 2010，23，17，，ExjadePraxibind，。

2010，23，17，，ExjadePraxibind，。

544px;text-align:justify;white-space:normal;background-color:#FFFFFF;text-indent:32px;line-height:2em;box-sizing:border-box ;'> The accelerated approval is also facing controversy.
Perhaps the most controversial is Sarepta's two exon skipping treatments for Duchenne muscular dystrophy, Exondys 51 and Vyondys 53 that received accelerated approval in 2016 and 2019, respectively.
The Exondys confirmatory MIS51ON study only started last year after severe criticism from the FDA, and the latter’s Essence study is estimated to have no results until 2024.
However, according to EvaluatePharma, a leading industry consulting and market research organization in the global pharmaceutical and health field, the combined sales of these two drugs are expected to exceed US$500 million based on fragile alternative indicators.

The accelerated approval is also facing controversy.
Perhaps the most controversial is Sarepta's two exon skipping treatments for Duchenne muscular dystrophy, Exondys 51 and Vyondys 53 that received accelerated approval in 2016 and 2019, respectively.
The Exondys confirmatory MIS51ON study only started last year after severe criticism from the FDA, and the latter’s Essence study is estimated to have no results until 2024.
However, according to EvaluatePharma, a leading industry consulting and market research organization in the global pharmaceutical and health field, the combined sales of these two drugs are expected to exceed US$500 million based on fragile alternative indicators.

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