We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Roche (RHHBY) Lung Cancer Drug Gets Positive CHMP Opinion
Read MoreHide Full Article
Roche (RHHBY - Free Report) has announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for Gavreto (pralsetinib).
Gavreto is a once-daily, oral targeted treatment designed to selectively target rearranged during transfection (RET) alterations, including fusions and mutations, regardless of the tissue of origin.
The committee has recommended the approval of the drug as a monotherapy for the treatment of adult patients with RET fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.
The CHMP recommendation was based on the results of the phase I/II ARROW study wherein Gavreto demonstrated rapid, potent, and durable clinical activity in patients with advanced RET fusion-positive NSCLC.
A final decision regarding the approval of Gavreto is expected from the European Commission in the coming months. Upon approval, the drug will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC.
We note that the drug was approved in the United States in September 2020 for the treatment of adults with metastatic RET fusion-positive NSCLC. In December 2020, the FDA approved the drug for another indication — the treatment of adult and pediatric patients 12 years of age and older with advanced RET-altered thyroid cancers.
Roche is co-developing Gavreto with Blueprint Medicines (BPMC - Free Report) globally. Both the companies commercialize Gavreto in the United States while Roche enjoys exclusive commercialization rights for Gavreto outside of the United States, except for certain territories in Asia, including China.
RET alterations are key disease drivers in many cancer types, including NSCLC and multiple types of thyroid cancer. Per the company, RET fusion-positive NSCLC affects approximately 37,500 people worldwide each year.
The approval will expand Roche’s portfolio of targeted treatments for NSCLC, which includes drugs like Alecensa (alectinib) and Rozlytrek (entrectinib). These three drugs are likely to offer personalised treatment options for almost one in 10 people with advanced NSCLC.
Shares of Roche have gained 5.1% so far this year compared with the industry’s growth of 8.5%.
Image Source: Zacks Investment Research
Roche also announced interim data from the phase II coopERA study evaluating neoadjuvant treatment with giredestrant (formerly known as GDC-9545), an investigational next-generation oral selective oestrogen receptor degrader (SERD), in post-menopausal women with ER-positive, HER2-negative early breast cancer at the European Society for Medical Oncology (ESMO) Congress 2021.
Data showed that after 14 days of treatment, giredestrant exhibited a reduction in Ki67, a prognostic marker that measures tumor proliferation compared to anastrozole. The successful development of new drugs bodes well for Roche as legacy drugs like Herceptin, Avastin, and MabThera face biosimilar competition.
Regeneron’s earnings estimates have been revised upward by 17.8% for 2021 and 13.8% for 2022 over the past 60 days. The stock has surged 35% year to date.
Ironwood's earnings estimates have been revised upward by 18% for 2021 and 45.7% for 2022 over the past 60 days. The stock has surged 8.5% year to date.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Roche (RHHBY) Lung Cancer Drug Gets Positive CHMP Opinion
Roche (RHHBY - Free Report) has announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for Gavreto (pralsetinib).
Gavreto is a once-daily, oral targeted treatment designed to selectively target rearranged during transfection (RET) alterations, including fusions and mutations, regardless of the tissue of origin.
The committee has recommended the approval of the drug as a monotherapy for the treatment of adult patients with RET fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.
The CHMP recommendation was based on the results of the phase I/II ARROW study wherein Gavreto demonstrated rapid, potent, and durable clinical activity in patients with advanced RET fusion-positive NSCLC.
A final decision regarding the approval of Gavreto is expected from the European Commission in the coming months. Upon approval, the drug will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC.
We note that the drug was approved in the United States in September 2020 for the treatment of adults with metastatic RET fusion-positive NSCLC. In December 2020, the FDA approved the drug for another indication — the treatment of adult and pediatric patients 12 years of age and older with advanced RET-altered thyroid cancers.
Roche is co-developing Gavreto with Blueprint Medicines (BPMC - Free Report) globally. Both the companies commercialize Gavreto in the United States while Roche enjoys exclusive commercialization rights for Gavreto outside of the United States, except for certain territories in Asia, including China.
RET alterations are key disease drivers in many cancer types, including NSCLC and multiple types of thyroid cancer. Per the company, RET fusion-positive NSCLC affects approximately 37,500 people worldwide each year.
The approval will expand Roche’s portfolio of targeted treatments for NSCLC, which includes drugs like Alecensa (alectinib) and Rozlytrek (entrectinib). These three drugs are likely to offer personalised treatment options for almost one in 10 people with advanced NSCLC.
Shares of Roche have gained 5.1% so far this year compared with the industry’s growth of 8.5%.
Image Source: Zacks Investment Research
Roche also announced interim data from the phase II coopERA study evaluating neoadjuvant treatment with giredestrant (formerly known as GDC-9545), an investigational next-generation oral selective oestrogen receptor degrader (SERD), in post-menopausal women with ER-positive, HER2-negative early breast cancer at the European Society for Medical Oncology (ESMO) Congress 2021.
Data showed that after 14 days of treatment, giredestrant exhibited a reduction in Ki67, a prognostic marker that measures tumor proliferation compared to anastrozole. The successful development of new drugs bodes well for Roche as legacy drugs like Herceptin, Avastin, and MabThera face biosimilar competition.
Roche currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the healthcare sector are Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Ironwood Pharmaceuticals (IRWD - Free Report) . Both carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings estimates have been revised upward by 17.8% for 2021 and 13.8% for 2022 over the past 60 days. The stock has surged 35% year to date.
Ironwood's earnings estimates have been revised upward by 18% for 2021 and 45.7% for 2022 over the past 60 days. The stock has surged 8.5% year to date.