The addition of anti-PD-L1, anti-PD-1 or anti-CTLA-4 checkpoint inhibitors to a single dose of the Triplet improved complete response
rates over either mRNA or antibody treatment alone.
At the end of 1st week, none of the subjects had complete response
. All the subjects of group A (100%) had partial response, 30% of subjects partial response and among group C subjects, 33.33% had no response and 66.67% had partial response.
It is the FDA's practice to send complete response
letters to sponsors of new drug applications when there are concerns about whether the drug should be approved and to outline information needed to complete the approval process.
Among patients with high-grade dysplasia at baseline, 83% retained complete response
(complete eradication of intestinal metaplasia) at 2 years in the intent-to-treat analysis; 88% did so in the per-protocol analysis.
The co-primary endpoints of the study were risk difference (RD) and risk ratio (RR) of pathologic complete response
in breast tissue and axillary lymph nodes, and the prespecified equivalence margins were +/-13 percent for RD and 0.759 to 1.318 for RR.
Neelapu said that Rituximab treatment alone usually achieves a 40 percent overall response rate and about 11 percent complete responses
, asserting that the side effect profile of the combination is about the same as rituximab alone.
Apixaban, a factor Xa inhibitor, is being reviewed by the FDA for this indication, but the agency has issued a complete response
letter requesting "additional information on data management and verification from the ARISTOTLE trial," one of the two large studies submitted to the FDA for approval of this indication, the statement said.
Instead, the agency will issue a "complete response
" letter at the end of the review period, the FDA has announced.
Overall remission rate was defined as complete response
, nodular partial response confirmed after eight weeks, and progression-free survival.
Jean-Luc Harousseau, of Hospital Hotel-Dieu, Nantes, France, a complete response
or a very good partial response following autologous stem cell transplant is associated with improved event-free and overall survival.
In addition, 23 of the patients (74%) achieved a complete response
Sarepta Therapeutics announced it had received a Complete Response
Letter, or CRL, from the FDA regarding the New Drug Application seeking accelerated approval of golodirsen injection for the treatment of Duchenne muscular dystrophy ) in patients with a confirmed mutation amenable to exon 53 skipping.