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The drug is an anti–PD-L1 inhibitor immunotherapy, and continues to be approved for use in lung and liver cancer and melanoma.
The manufacturer, Genentech, announced that it was voluntarily withdrawing the U.S. indication for atezolizumab that covered its use in adults with locally advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
The company said that it made the decision after consultation with the Food and Drug Administration.
“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval Program, which brings innovative medicines to patients sooner,” said Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global Product Development.
Atezolizumab had been granted an accelerated approval for this indication back in 2016, based on response rate data from the IMvigor210 trial.
The company was obliged to conduct a follow-up trial to show clinical benefit, and launched IMvigor130, which it described as “the designated postmarketing requirement to convert the accelerated approval to regular approval.”
The bladder cancer indication for atezolizumab was discussed (alongside several other indications for different immunotherapy drugs) at a historic 3-day meeting of the FDA’s oncologic Drugs Advisory Committee in April 2021. At the time, ODAC voted 10-1 in favor of maintaining the indication for atezolizumab for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.
Genentech has now said that this trial “did not meet the coprimary endpoint of overall survival for atezolizumab plus chemotherapy compared with chemotherapy alone” when used for the first-line treatment of patients with previously untreated advanced bladder cancer.
These data will be presented at an upcoming medical meeting, the company added.
“There is a considerable unmet need for effective and tolerable treatments for people living with advanced bladder cancer and so we regret that the IMvigor130 trial did not cross the statistical threshold for overall survival,” Dr. Garraway commented.
A version of this article first appeared on Medscape.com.
The drug is an anti–PD-L1 inhibitor immunotherapy, and continues to be approved for use in lung and liver cancer and melanoma.
The manufacturer, Genentech, announced that it was voluntarily withdrawing the U.S. indication for atezolizumab that covered its use in adults with locally advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
The company said that it made the decision after consultation with the Food and Drug Administration.
“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval Program, which brings innovative medicines to patients sooner,” said Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global Product Development.
Atezolizumab had been granted an accelerated approval for this indication back in 2016, based on response rate data from the IMvigor210 trial.
The company was obliged to conduct a follow-up trial to show clinical benefit, and launched IMvigor130, which it described as “the designated postmarketing requirement to convert the accelerated approval to regular approval.”
The bladder cancer indication for atezolizumab was discussed (alongside several other indications for different immunotherapy drugs) at a historic 3-day meeting of the FDA’s oncologic Drugs Advisory Committee in April 2021. At the time, ODAC voted 10-1 in favor of maintaining the indication for atezolizumab for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.
Genentech has now said that this trial “did not meet the coprimary endpoint of overall survival for atezolizumab plus chemotherapy compared with chemotherapy alone” when used for the first-line treatment of patients with previously untreated advanced bladder cancer.
These data will be presented at an upcoming medical meeting, the company added.
“There is a considerable unmet need for effective and tolerable treatments for people living with advanced bladder cancer and so we regret that the IMvigor130 trial did not cross the statistical threshold for overall survival,” Dr. Garraway commented.
A version of this article first appeared on Medscape.com.
The drug is an anti–PD-L1 inhibitor immunotherapy, and continues to be approved for use in lung and liver cancer and melanoma.
The manufacturer, Genentech, announced that it was voluntarily withdrawing the U.S. indication for atezolizumab that covered its use in adults with locally advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
The company said that it made the decision after consultation with the Food and Drug Administration.
“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval Program, which brings innovative medicines to patients sooner,” said Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global Product Development.
Atezolizumab had been granted an accelerated approval for this indication back in 2016, based on response rate data from the IMvigor210 trial.
The company was obliged to conduct a follow-up trial to show clinical benefit, and launched IMvigor130, which it described as “the designated postmarketing requirement to convert the accelerated approval to regular approval.”
The bladder cancer indication for atezolizumab was discussed (alongside several other indications for different immunotherapy drugs) at a historic 3-day meeting of the FDA’s oncologic Drugs Advisory Committee in April 2021. At the time, ODAC voted 10-1 in favor of maintaining the indication for atezolizumab for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.
Genentech has now said that this trial “did not meet the coprimary endpoint of overall survival for atezolizumab plus chemotherapy compared with chemotherapy alone” when used for the first-line treatment of patients with previously untreated advanced bladder cancer.
These data will be presented at an upcoming medical meeting, the company added.
“There is a considerable unmet need for effective and tolerable treatments for people living with advanced bladder cancer and so we regret that the IMvigor130 trial did not cross the statistical threshold for overall survival,” Dr. Garraway commented.
A version of this article first appeared on Medscape.com.
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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Atezolizumab (Tecentriq) is no longer approved in the United States for use in certain patients with bladder or urinary tract cancer.</metaDescription> <articlePDF/> <teaserImage/> <title>Atezolizumab (Tecentriq) bladder cancer indication withdrawn in United States</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords> <keyword>Genitourinary cancer/bladder</keyword> </keywords> <seeAlsos/> <publications_g> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>oncr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>21</term> <term canonical="true">31</term> </publications> <sections> <term canonical="true">37225</term> <term>39313</term> </sections> <topics> <term>263</term> <term canonical="true">214</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Atezolizumab (Tecentriq) bladder cancer indication withdrawn in United States</title> <deck/> </itemMeta> <itemContent> <p> <span class="tag metaDescription"><span class="Hyperlink">Atezolizumab</span> (Tecentriq) is no longer approved in the United States for use in certain patients with bladder or urinary tract cancer.</span> </p> <p>The drug is an anti–PD-L1 inhibitor immunotherapy, and continues to be approved for use in lung and <span class="Hyperlink">liver cancer</span> and <span class="Hyperlink">melanoma</span>.<br/><br/>The manufacturer, Genentech, <span class="Hyperlink"><a href="https://www.gene.com/media/statements/ps_112822">announced that it was voluntarily withdrawing</a></span> the U.S. indication for atezolizumab that covered its use in adults with locally advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. <br/><br/>The company said that it made the decision after consultation with the Food and Drug Administration.<br/><br/>“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval Program, which brings innovative medicines to patients sooner,” said Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global Product Development.<br/><br/>Atezolizumab had been granted an <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/863453">accelerated approval for this indication</a></span> back in 2016, based on response rate data from the IMvigor210 trial.<br/><br/>The company was obliged to conduct a follow-up trial to show clinical benefit, and launched IMvigor130, which it described as “the designated postmarketing requirement to convert the accelerated approval to regular approval.”<br/><br/>The <span class="Hyperlink">bladder cancer</span> indication for atezolizumab was discussed (alongside several other indications for different immunotherapy drugs) at a historic 3-day meeting of the FDA’s oncologic Drugs Advisory Committee in <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/950165">April 2021. At the time</a></span>, ODAC voted 10-1 in favor of maintaining the indication for atezolizumab for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.<br/><br/>Genentech has now said that this trial “did not meet the coprimary endpoint of overall survival for atezolizumab plus chemotherapy compared with chemotherapy alone” when used for the first-line treatment of patients with previously untreated advanced bladder cancer.<br/><br/>These data will be presented at an upcoming medical meeting, the company added.<br/><br/>“There is a considerable unmet need for effective and tolerable treatments for people living with advanced bladder cancer and so we regret that the IMvigor130 trial did not cross the statistical threshold for overall survival,” Dr. Garraway commented. <span class="end"/> </p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/984722">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> <p>The anti–PD-L1 inhibitor continues to be approved for lung and <span class="Hyperlink">liver cancers and melanoma.</span></p> </itemContent> </newsItem> </itemSet></root>