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Roche (RHHBY) Gets Approval for Gavreto for NSCLC in EU
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Roche (RHHBY - Free Report) recently announced that the European Commission has granted conditional marketing authorization to Gavreto (pralsetinib).
Following this authorization, Gavreto has been approved in the European Union (“EU”) as a monotherapy for the treatment of adults with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.
Per the company, Gavreto is the first and only precision medicine approved in the EU for the first-line treatment of this patient population.
The conditional approval is based on results from the phase I/II ARROW study wherein Gavreto led to durable responses in patients with RET fusion-positive advanced NSCLC.
The study data showed that in 75 treatment-naïve patients, Gavreto demonstrated an overall response rate (ORR) of 72% while the median duration of response (DOR) was not reached. Gavreto demonstrated an ORR of 58.8% and median DOR was 22.3 months in 136 patients who had previously received platinum-based chemotherapy.
The approval will strengthen Roche’s strong lung cancer portfolio, which comprises Gavreto in RET fusion-positive advanced NSCLC, Alecensa (alectinib) in ALK-positive advanced NSCLC and Rozlytrek (entrectinib) in ROS1-positive advanced NSCLC.
Shares of Roche have gained 13.5% so far this year compared with the industry’s growth of 15.2%.
Image Source: Zacks Investment Research
Roche has a solid and broad oncology portfolio and approval of additional drugs or label expansion of existing drugs will further boost it.
Gavreto is approved in the United States for the treatment of adults with metastatic RET fusion-positive NSCLC and the treatment of adult and pediatric patients 12 years of age and older with advanced RET-altered thyroid cancers.
A submission for RET-altered thyroid cancers is planned in the EU as well.
We note that Roche and Blueprint Medicines (BPMC - Free Report) are co-developing Gavreto globally for treating people with various types of RET-altered cancers, with the exception of certain territories in Asia, including China.
While Blueprint Medicines and Genentech (a wholly owned member of the Roche Group) commercialize Gavreto in the United States, Roche has exclusive commercialization rights for Gavreto outside of the United States with the exception of certain territories in Asia, including China.
Loss per share estimates for Sarepta have narrowed from $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022 in the past 30 days. Sarepta delivered an earnings surprise of 11.06%, on average, in the last four quarters.
Loss per share estimates for Viking Therapeutics have narrowed to 74 cents from 81 cents for 2021 and to $1.08 from $1.18 for 2022 in the past 30 days. Viking delivered an earnings surprise of 2.06%, on average, in the last four quarters.
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Roche (RHHBY) Gets Approval for Gavreto for NSCLC in EU
Roche (RHHBY - Free Report) recently announced that the European Commission has granted conditional marketing authorization to Gavreto (pralsetinib).
Following this authorization, Gavreto has been approved in the European Union (“EU”) as a monotherapy for the treatment of adults with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.
Per the company, Gavreto is the first and only precision medicine approved in the EU for the first-line treatment of this patient population.
The conditional approval is based on results from the phase I/II ARROW study wherein Gavreto led to durable responses in patients with RET fusion-positive advanced NSCLC.
The study data showed that in 75 treatment-naïve patients, Gavreto demonstrated an overall response rate (ORR) of 72% while the median duration of response (DOR) was not reached. Gavreto demonstrated an ORR of 58.8% and median DOR was 22.3 months in 136 patients who had previously received platinum-based chemotherapy.
The approval will strengthen Roche’s strong lung cancer portfolio, which comprises Gavreto in RET fusion-positive advanced NSCLC, Alecensa (alectinib) in ALK-positive advanced NSCLC and Rozlytrek (entrectinib) in ROS1-positive advanced NSCLC.
Shares of Roche have gained 13.5% so far this year compared with the industry’s growth of 15.2%.
Roche has a solid and broad oncology portfolio and approval of additional drugs or label expansion of existing drugs will further boost it.
Gavreto is approved in the United States for the treatment of adults with metastatic RET fusion-positive NSCLC and the treatment of adult and pediatric patients 12 years of age and older with advanced RET-altered thyroid cancers.
A submission for RET-altered thyroid cancers is planned in the EU as well.
We note that Roche and Blueprint Medicines (BPMC - Free Report) are co-developing Gavreto globally for treating people with various types of RET-altered cancers, with the exception of certain territories in Asia, including China.
While Blueprint Medicines and Genentech (a wholly owned member of the Roche Group) commercialize Gavreto in the United States, Roche has exclusive commercialization rights for Gavreto outside of the United States with the exception of certain territories in Asia, including China.
Zacks Rank and Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Sarepta Therapeutics (SRPT - Free Report) and Viking Therapeutics (VKTX - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for Sarepta have narrowed from $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022 in the past 30 days. Sarepta delivered an earnings surprise of 11.06%, on average, in the last four quarters.
Loss per share estimates for Viking Therapeutics have narrowed to 74 cents from 81 cents for 2021 and to $1.08 from $1.18 for 2022 in the past 30 days. Viking delivered an earnings surprise of 2.06%, on average, in the last four quarters.