Key takeaways:
- The FDA denied glofitamab as second-line DLBCL remedy, noting inadequate proof for U.S. inhabitants.
- Glofitamab confirmed decreased threat for demise, however greater charges of antagonistic occasions vs. rituximab.
The FDA issued a whole response letter to Genentech indicating it can’t approve the corporate’s biologic license software in search of approval for glofitamab-gxbm as a remedy for relapsed or refractory diffuse massive B-cell lymphoma.
In its letter, the company cited that information from the section 3 STARGLO examine failed to supply ample proof to assist glofitamab-gxbm (Columvi) as second-line remedy together with gemcitabine and oxaliplatin (GemOx) for a U.S. inhabitants with relapsed/refractory DLBCL.
The FDA issued a whole response letter for glofitamab-gxbm in relapsed or refractory diffuse massive B-cell lymphoma.
“Whereas we’re disenchanted with this final result, we stay assured within the information supporting the worth of Columvi for U.S. sufferers who’ve relapsed following preliminary remedy, and its key position as monotherapy within the third-line setting,” Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of world product growth, mentioned within the launch. “We’re dedicated to bringing Columvi to extra individuals residing with lymphoma and are actively exploring its potential in further remedy settings, together with as front-line remedy.”
Initially supposed to be a postmarketing confirmatory examine, STARGLO examined the drug’s security and efficacy in sufferers with relapsed/refractory DLBCL who had obtained no less than one prior line of remedy and weren’t candidates for autologous stem cell transplant, or who had obtained two or extra prior strains of remedy.
In keeping with the discharge, outcomes of STARGLO demonstrated a statistically vital and clinically significant 41% discount within the threat for demise (HR = 0.59, 95% CI, 0.4-0.89) for sufferers handled with the glofitamab-GemOx routine. Nonetheless, greater charges of antagonistic occasion have been reported with the glofitamab routine in contrast with rituximab, with critical antagonistic occasions reported amongst 52.3% vs. 17% of sufferers.
“For sufferers with this aggressive type of lymphoma, efficient remedy after relapse is paramount,” Jeremy Abramson, MD, director of the Jon and Jo Ann Hagler Heart for Lymphoma at Massachusetts Normal Hospital Most cancers Heart and principal investigator of STARGLO, mentioned within the launch. “The STARGLO examine confirmed that Columvi-GemOx considerably improves general survival and will have a constructive impression for sufferers earlier of their remedy journey. This routine is already permitted in over 35 international locations, which underscores the pressing want it addresses.”
Genentech reported that glofitamab retains its accelerated approval standing as a third-line remedy for DLBCL. The corporate famous that it plans to pursue discussions with the FDA on whether or not the continued section 3 SKYGLO examine — which is evaluating security and efficacy of glofitamab together with polatuzumab vedotin-piiq (Polivy, Genentech), rituximab, cyclophosphamide, doxorubicin and prednisone — can fulfill the postmarketing examine requirement.
