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Glaxo's Multiple Myeloma Candidate Gets FDA Committee Nod
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GlaxoSmithKline plc (GSK - Free Report) announced that an FDA advisory committee has voted in favor of its antibody drug conjugate, belantamab mafodotin for heavily pre-treated multiple myeloma.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12-0 in favor of the benefits of belantamab mafodotin outweighing risks as a monotherapy for the treatment of relapsed/refractory multiple myeloma in patients who have been previously treated with at least four therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Though the FDA is not obligated to follow the advisory committee’s decision, it usually follows it.
We remind investors that the FDA had granted priority review to Glaxo’s biologics license application (BLA) seeking approval of belantamab mafodotin. A similar application is also under review in the EU.
The BLA was based on data from the pivotal DREAMM-2 study, which evaluated two doses of belantamab mafodotin in patients with heavily pre-treated multiple myeloma. Detailed results from the above-mentioned study showed that treatment with belantamab mafodotin led to clinically meaningful 31% overall response rate (ORR) under the 2.5 mg/kg regimen in such patients.
Per the company, belantamab mafodotin has potential to be the first anti-BCMA treatment available to the given patient population. The candidate is also being evaluated in several studies for other forms of multiple myeloma.
So far this year, Glaxo’s shares have declined 13.4% compared with the industry’s 1.4% decrease.
Belantamab mafodotin is part of Glaxo’s oncology pipeline. The company has made significant progress in its oncology pipeline and doubled its assets in development since early 2018. This has been achieved through advancement of internal programs as well as targeted business development including the January 2019 acquisition of Tesaro (which added key PARP inhibitor Zejula) and the February 2019 global alliance with Merck KGaA (to co-develop bintrafusp alpha/M7824, a promising new oncology medicine).
Meanwhile, Glaxo now has a number of molecules with diverse mechanisms of action, providing an opportunity for many innovative cancer combinations. Meanwhile, it divested its non-core Consumer Healthcare (CHC) nutrition business to Unilever (UL - Free Report) and has formed a new Consumer HealthCare joint venture with Pfizer (PFE - Free Report) to focus on its pharmaceuticals business, particularly oncology.
A better-ranked large cap pharma stock is Eli Lilly (LLY - Free Report) , which has a Zacks Rank of 1. Its earnings estimates have risen from $6.81 per share to $6.82 per share for 2020 over the past 60 days. The stock is up 24.7% this year so far.
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Glaxo's Multiple Myeloma Candidate Gets FDA Committee Nod
GlaxoSmithKline plc (GSK - Free Report) announced that an FDA advisory committee has voted in favor of its antibody drug conjugate, belantamab mafodotin for heavily pre-treated multiple myeloma.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12-0 in favor of the benefits of belantamab mafodotin outweighing risks as a monotherapy for the treatment of relapsed/refractory multiple myeloma in patients who have been previously treated with at least four therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Though the FDA is not obligated to follow the advisory committee’s decision, it usually follows it.
We remind investors that the FDA had granted priority review to Glaxo’s biologics license application (BLA) seeking approval of belantamab mafodotin. A similar application is also under review in the EU.
The BLA was based on data from the pivotal DREAMM-2 study, which evaluated two doses of belantamab mafodotin in patients with heavily pre-treated multiple myeloma. Detailed results from the above-mentioned study showed that treatment with belantamab mafodotin led to clinically meaningful 31% overall response rate (ORR) under the 2.5 mg/kg regimen in such patients.
Per the company, belantamab mafodotin has potential to be the first anti-BCMA treatment available to the given patient population. The candidate is also being evaluated in several studies for other forms of multiple myeloma.
So far this year, Glaxo’s shares have declined 13.4% compared with the industry’s 1.4% decrease.
Belantamab mafodotin is part of Glaxo’s oncology pipeline. The company has made significant progress in its oncology pipeline and doubled its assets in development since early 2018. This has been achieved through advancement of internal programs as well as targeted business development including the January 2019 acquisition of Tesaro (which added key PARP inhibitor Zejula) and the February 2019 global alliance with Merck KGaA (to co-develop bintrafusp alpha/M7824, a promising new oncology medicine).
Meanwhile, Glaxo now has a number of molecules with diverse mechanisms of action, providing an opportunity for many innovative cancer combinations. Meanwhile, it divested its non-core Consumer Healthcare (CHC) nutrition business to Unilever (UL - Free Report) and has formed a new Consumer HealthCare joint venture with Pfizer (PFE - Free Report) to focus on its pharmaceuticals business, particularly oncology.
Glaxo currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A better-ranked large cap pharma stock is Eli Lilly (LLY - Free Report) , which has a Zacks Rank of 1. Its earnings estimates have risen from $6.81 per share to $6.82 per share for 2020 over the past 60 days. The stock is up 24.7% this year so far.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
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