Mon May 19, 2014 6:43pm EDT
<span id="articleText"/>(Reuters) - GlaxoSmithKline and Danish biotech company Genmab said disappointing results from a study on treating relapsed lymphoma with their ofatumumab drug meant it was unlikely they would seek its regulatory approval.
<span id="midArticle_0"/>A head-to-head phase III study of ofatumumab and another drug to fight the fast-growing blood cancer failed to meet the companies' goals. Results showed no significant difference in progression free survival (PFS) between one treatment arm and the other, the companies said in a statement late on Monday.
<span id="midArticle_1"/>"Based on today's results we are unlikely to move forward with a regulatory filing," Jan Van De Winkel, Genmab chief executive said in the statement.
<span id="midArticle_2"/>The companies tested PFS, a measure of the health of a person taking a treatment to fight a disease, among patients using ofatumumab (Arzerra(TM)) plus chemotherapy versus rituximab plus chemotherapy for the lymphoma of the B-cells known as DLBCL.
<span id="midArticle_3"/>The Orcharrd phase III study involved 447 patients who were refractory to, or had relapsed following, first-line treatment with rituximab in combination with a chemotherapy regimen containing anthracycline or anthracenedione.
<span id="midArticle_4"/>Arzerra is being developed under an agreement between Genmab and GSK and is not approved or licensed anywhere in the world for the treatment of DLBCL.
<span id="midArticle_5"/>GSK and Genmab said dose interruptions and delays due to infusion reactions and increased serum creatinine in the ofatumumab plus chemotherapy arm required further analysis.
<span id="midArticle_6"/><span id="midArticle_7"/>(Reporting by Aashika Jain in Bangalore; editing by Andrew Hay)
<span id="midArticle_8"/>
<span id="articleText"/>(Reuters) - GlaxoSmithKline and Danish biotech company Genmab said disappointing results from a study on treating relapsed lymphoma with their ofatumumab drug meant it was unlikely they would seek its regulatory approval.
<span id="midArticle_0"/>A head-to-head phase III study of ofatumumab and another drug to fight the fast-growing blood cancer failed to meet the companies' goals. Results showed no significant difference in progression free survival (PFS) between one treatment arm and the other, the companies said in a statement late on Monday.
<span id="midArticle_1"/>"Based on today's results we are unlikely to move forward with a regulatory filing," Jan Van De Winkel, Genmab chief executive said in the statement.
<span id="midArticle_2"/>The companies tested PFS, a measure of the health of a person taking a treatment to fight a disease, among patients using ofatumumab (Arzerra(TM)) plus chemotherapy versus rituximab plus chemotherapy for the lymphoma of the B-cells known as DLBCL.
<span id="midArticle_3"/>The Orcharrd phase III study involved 447 patients who were refractory to, or had relapsed following, first-line treatment with rituximab in combination with a chemotherapy regimen containing anthracycline or anthracenedione.
<span id="midArticle_4"/>Arzerra is being developed under an agreement between Genmab and GSK and is not approved or licensed anywhere in the world for the treatment of DLBCL.
<span id="midArticle_5"/>GSK and Genmab said dose interruptions and delays due to infusion reactions and increased serum creatinine in the ofatumumab plus chemotherapy arm required further analysis.
<span id="midArticle_6"/><span id="midArticle_7"/>(Reporting by Aashika Jain in Bangalore; editing by Andrew Hay)
<span id="midArticle_8"/>
- Link this
- Share this
- Digg this
- Reprints
via Smart Health Shop Forum http://ift.tt/1lYEhDp
No comments:
Post a Comment