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Roche (RHHBY) Withdraws Tecentriq for Breast Cancer in the U.S.
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Roche (RHHBY - Free Report) has announced that it will withdraw immuno-oncology drug Tecentriq (atezolizumab) in the United States for the indication of breast cancer. It was used in combination with chemotherapy for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.
We remind investors that the drug was granted accelerated approval by the FDA for the mTNBC indication in March 2019. The accelerated approval was based on the progression-free survival (PFS) results of the phase III IMpassion130 study for patients with mTNBC whose tumors express PD-L1 (≥1%). The continued approval for this indication was contingent upon the results of IMpassion131, the postmarketing requirement (PMR).
However, Tecentriq failed to meet this requirement. This study did not meet its primary endpoint of PFS for the first-line treatment of the above-mentioned patient population.
Shares of Roche have gained 13.5% so far this year compared with the industry’s growth of 15.8%.
Image Source: Zacks Investment Research
In April 2021, the FDA Oncology Drugs Advisory Committee (“ODAC”) voted 7:2 in favor of maintaining the accelerated approval of Tecentriq in combination with nab-paclitaxel for the treatment of people with PD-L1-positive mTNBC.
Thereafter, Roche has been working with the FDA on a possible alternative PMR. The company stated that due to the recent changes in the treatment landscape, the regulatory body does not consider it appropriate to maintain the accelerated approval anymore.
Hence, Roche decided to voluntarily withdraw the mTNBC indication from the United States.
Earlier, in March 2021, Roche also withdrew the drug for the indication of prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer).
The withdrawal of these indications from the U.S. market will affect sales of the drug, which came in at CHF 1.6 billion in the first half of 2021.
We note that Tecentriq is approved in the United States, the EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), among others.
Last month, Bristol Myers Squibb (BMY - Free Report) also announced that it will voluntarily withdraw Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib from the United States market. The drug was also approved under the FDA’s accelerated approval program based on tumor responses from the phase I/II CheckMate -040 trial. However, CheckMate -459, the confirmatory randomized study of Opdivo versus Nexavar in the first-line setting, did not achieve statistical significance for its primary endpoint of overall survival per the pre-specified analysis.
Merck (MRK - Free Report) has also decided to withdraw the accelerated approval indication for Keytruda for the treatment of third-line gastric cancer in the United States.
Image: Bigstock
Roche (RHHBY) Withdraws Tecentriq for Breast Cancer in the U.S.
Roche (RHHBY - Free Report) has announced that it will withdraw immuno-oncology drug Tecentriq (atezolizumab) in the United States for the indication of breast cancer. It was used in combination with chemotherapy for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.
We remind investors that the drug was granted accelerated approval by the FDA for the mTNBC indication in March 2019. The accelerated approval was based on the progression-free survival (PFS) results of the phase III IMpassion130 study for patients with mTNBC whose tumors express PD-L1 (≥1%). The continued approval for this indication was contingent upon the results of IMpassion131, the postmarketing requirement (PMR).
However, Tecentriq failed to meet this requirement. This study did not meet its primary endpoint of PFS for the first-line treatment of the above-mentioned patient population.
Shares of Roche have gained 13.5% so far this year compared with the industry’s growth of 15.8%.
Image Source: Zacks Investment Research
In April 2021, the FDA Oncology Drugs Advisory Committee (“ODAC”) voted 7:2 in favor of maintaining the accelerated approval of Tecentriq in combination with nab-paclitaxel for the treatment of people with PD-L1-positive mTNBC.
Thereafter, Roche has been working with the FDA on a possible alternative PMR. The company stated that due to the recent changes in the treatment landscape, the regulatory body does not consider it appropriate to maintain the accelerated approval anymore.
Hence, Roche decided to voluntarily withdraw the mTNBC indication from the United States.
Earlier, in March 2021, Roche also withdrew the drug for the indication of prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer).
The withdrawal of these indications from the U.S. market will affect sales of the drug, which came in at CHF 1.6 billion in the first half of 2021.
We note that Tecentriq is approved in the United States, the EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), among others.
Last month, Bristol Myers Squibb (BMY - Free Report) also announced that it will voluntarily withdraw Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib from the United States market. The drug was also approved under the FDA’s accelerated approval program based on tumor responses from the phase I/II CheckMate -040 trial. However, CheckMate -459, the confirmatory randomized study of Opdivo versus Nexavar in the first-line setting, did not achieve statistical significance for its primary endpoint of overall survival per the pre-specified analysis.
Merck (MRK - Free Report) has also decided to withdraw the accelerated approval indication for Keytruda for the treatment of third-line gastric cancer in the United States.
Roche currently has a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Repligen Corporation (RGEN - Free Report) which has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Earnings estimates for Repligen for 2021 are up 7 cents in the past 30 days. The stock is up 47.7% in the year so far.