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Roche Gets CHMP Opinion for Breast Cancer & Lymphoma Drugs
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Roche Holding AG (RHHBY - Free Report) ) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Kadcyla (trastuzumab emtansine) for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment. The company has licensed the technology for the drug under an agreement with ImmunoGen, Inc .
The CHMP recommendation is supported by data from phase III KATHERINE study, evaluating the efficacy and safety of Kadcyla compared to Herceptin (trastuzumab) as an adjuvant therapy in people with HER2-positive early breast cancer, who have pathological invasive residual disease in the breast or axillary lymph nodes following neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy. The study showed that Kadcyla reduced the risk of disease recurrence or death by half compared to Herceptin in the adjuvant setting for specific patients with HER2-positive early breast cancer. At three years, 88.3% of people treated with Kadcyla did not see a recurrence in breast cancer compared to 77% treated with Herceptin.
The KATHERINE study data were also used by the FDA to accelerate the approval of Kadcylafor the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment in May. Based on the CHMP's recommendation, Roche expects a final decision regarding the approval of trastuzumab emtansine in this setting from the European Commission in the near future.
Shares of the company have rallied 20.7% compared with the industry’s growth of 4.7%.
We remind investors that last month another company, AstraZeneca Plc. (AZN - Free Report) , received priority review from the FDA for the biologics license application (“BLA”) for their antibody drug-conjugate candidate, trastuzumab deruxtecan. The BLA was filed to get FDA’s approval for the candidate as a potential treatment for HER2-positive metastatic breast cancer (“MBC”).
Roche also received positive opinion by the CHMP for Polivy (polatuzumab vedotin) in combination with bendamustine plus MabThera (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who are not candidates for a haematopoietic stem cell transplant.
The positive CHMP opinion is based on the results from the phase Ib/II GO29365 study, the first and only clinical trial to show higher response rates and improved overall survival (OS) compared to BR, a commonly used regimen, in people with R/R DLBCL who are not candidates for a hematopoietic stem cell transplant.
Separately, Roche entered an agreement to acquire a clinical-stage biotechnology company, Promedior, Inc. Per the agreement, Roche will make an upfront cash payment of $390 million plus additional contingent payments of up to $1 billion, based on the achievement of certain predetermined development, regulatory and commercial milestones.
With the acquisition, Roche will obtain full rights to Promedior's entire portfolio of molecules for serious fibrotic diseases, particularly PRM-151. PRM-151 is Promedior's lead pipeline candidate and a first-in-class recombinant human Pentraxin-2. The candidate has shown broad anti-fibrotic activity in multiple preclinical models of fibrotic disease. Phase II study results showed that PRM-151 was the first molecule to show significant lung function improvements on top of current therapies in idiopathic pulmonary fibrosis (IPF).
Roche already has an IPF medicine, Esbriet, which generated sales of about $1 billion in 2018. Due to the company's strong expertise in IPF, hematological cancer and other fibrotic disorders, it will be instrumental in providing new treatment options within these areas of urgent unmet medical need.
Roche Holding AG Price, Consensus and EPS Surprise
Glaxo’s’ earnings per share estimates have increased from $2.96 to $3.08 for 2019 and from $3.01 to $3.02 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 17.23% on average.
7 Best Stocks for the Next 30 Days
Just released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers “Most Likely for Early Price Pops.” Since 1988, the full list has beaten the market more than 2X over with an average gain of +24.5% per year. So be sure to give these hand-picked 7 your immediate attention.
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Roche Gets CHMP Opinion for Breast Cancer & Lymphoma Drugs
Roche Holding AG (RHHBY - Free Report) ) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Kadcyla (trastuzumab emtansine) for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment. The company has licensed the technology for the drug under an agreement with ImmunoGen, Inc .
The CHMP recommendation is supported by data from phase III KATHERINE study, evaluating the efficacy and safety of Kadcyla compared to Herceptin (trastuzumab) as an adjuvant therapy in people with HER2-positive early breast cancer, who have pathological invasive residual disease in the breast or axillary lymph nodes following neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy. The study showed that Kadcyla reduced the risk of disease recurrence or death by half compared to Herceptin in the adjuvant setting for specific patients with HER2-positive early breast cancer. At three years, 88.3% of people treated with Kadcyla did not see a recurrence in breast cancer compared to 77% treated with Herceptin.
The KATHERINE study data were also used by the FDA to accelerate the approval of Kadcylafor the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment in May. Based on the CHMP's recommendation, Roche expects a final decision regarding the approval of trastuzumab emtansine in this setting from the European Commission in the near future.
Shares of the company have rallied 20.7% compared with the industry’s growth of 4.7%.
We remind investors that last month another company, AstraZeneca Plc. (AZN - Free Report) , received priority review from the FDA for the biologics license application (“BLA”) for their antibody drug-conjugate candidate, trastuzumab deruxtecan. The BLA was filed to get FDA’s approval for the candidate as a potential treatment for HER2-positive metastatic breast cancer (“MBC”).
Roche also received positive opinion by the CHMP for Polivy (polatuzumab vedotin) in combination with bendamustine plus MabThera (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who are not candidates for a haematopoietic stem cell transplant.
The positive CHMP opinion is based on the results from the phase Ib/II GO29365 study, the first and only clinical trial to show higher response rates and improved overall survival (OS) compared to BR, a commonly used regimen, in people with R/R DLBCL who are not candidates for a hematopoietic stem cell transplant.
Separately, Roche entered an agreement to acquire a clinical-stage biotechnology company, Promedior, Inc. Per the agreement, Roche will make an upfront cash payment of $390 million plus additional contingent payments of up to $1 billion, based on the achievement of certain predetermined development, regulatory and commercial milestones.
With the acquisition, Roche will obtain full rights to Promedior's entire portfolio of molecules for serious fibrotic diseases, particularly PRM-151. PRM-151 is Promedior's lead pipeline candidate and a first-in-class recombinant human Pentraxin-2. The candidate has shown broad anti-fibrotic activity in multiple preclinical models of fibrotic disease. Phase II study results showed that PRM-151 was the first molecule to show significant lung function improvements on top of current therapies in idiopathic pulmonary fibrosis (IPF).
Roche already has an IPF medicine, Esbriet, which generated sales of about $1 billion in 2018. Due to the company's strong expertise in IPF, hematological cancer and other fibrotic disorders, it will be instrumental in providing new treatment options within these areas of urgent unmet medical need.
Roche Holding AG Price, Consensus and EPS Surprise
Roche Holding AG price-consensus-eps-surprise-chart | Roche Holding AG Quote
Zacks Rank & Another Stock to Consider
Roche currently carries a Zacks Rank #2 (Buy).
A top-ranked stock in the same space is GlaxoSmithKline Plc. (GSK - Free Report) , carrying Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Glaxo’s’ earnings per share estimates have increased from $2.96 to $3.08 for 2019 and from $3.01 to $3.02 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 17.23% on average.
7 Best Stocks for the Next 30 Days
Just released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers “Most Likely for Early Price Pops.” Since 1988, the full list has beaten the market more than 2X over with an average gain of +24.5% per year. So be sure to give these hand-picked 7 your immediate attention.
See them now >>