Roche Holding Moves Ahead in Cancer Drugs Race; Wins Expanded FDA Approval for Gazyva. Roche Holding Ltd. blood cancer drug, Gazyva, has been approved by the Food and Drug Administration (FDA), in combination with bendamustine chemotherapy, followed by Gazyva alone, for treating follicular lymphoma.
Gazyva is now approved for two types of blood cancer. The drug is already approved, in combination with chlorambucil, for treating patients who suffer from chronic lymphocytic leukemia (CLL), and had received no other treatment before. The approved drug is for patients who received Rituxan (rituximab)-containing regimen; however, their cancer relapsed after the treatment.
The FDA approval has come on the back of positive results from a late-stage study, named GADOLIN, which was terminated midway, as it proved to meet primary goals. The trial aimed at evaluating the efficacy of Gazyva, given in combination with bendamustine, and followed by Gazyva alone. The said treatment was successful in leading to a 52% decrease in risk of cancer spread or death in patients, who received Rituxan-based treatment.
Sandra Horning, the chief medical officer and head of Global Product Development at Roche, seemed very positive about the drug's high revenue generating potential. As per the company press release on Friday, she commented: “People with follicular lymphoma whose disease returns or worsens despite treatment with a Rituxan-containing regimen need more options because the disease becomes more difficult to treat each time it comes back. Gazyva plus bendamustine provides a new treatment option that can be used after relapse to significantly reduce the risk of progression or death.”
Roche stock gained 0.77% to touch $32.9 in mid-day trading on Friday. The stock closed at $32.66, being up by 0.03%.
Gazyva is now approved for two types of blood cancer. The drug is already approved, in combination with chlorambucil, for treating patients who suffer from chronic lymphocytic leukemia (CLL), and had received no other treatment before. The approved drug is for patients who received Rituxan (rituximab)-containing regimen; however, their cancer relapsed after the treatment.
The FDA approval has come on the back of positive results from a late-stage study, named GADOLIN, which was terminated midway, as it proved to meet primary goals. The trial aimed at evaluating the efficacy of Gazyva, given in combination with bendamustine, and followed by Gazyva alone. The said treatment was successful in leading to a 52% decrease in risk of cancer spread or death in patients, who received Rituxan-based treatment.
Sandra Horning, the chief medical officer and head of Global Product Development at Roche, seemed very positive about the drug's high revenue generating potential. As per the company press release on Friday, she commented: “People with follicular lymphoma whose disease returns or worsens despite treatment with a Rituxan-containing regimen need more options because the disease becomes more difficult to treat each time it comes back. Gazyva plus bendamustine provides a new treatment option that can be used after relapse to significantly reduce the risk of progression or death.”
Roche stock gained 0.77% to touch $32.9 in mid-day trading on Friday. The stock closed at $32.66, being up by 0.03%.
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