The FDA granted approval of Breyanzi to Juno Therapeutics Inc., a Bristol-Myers Squibb Company.Efficacy was evaluated in TRANSFORM (NCT03575351), a randomized, open-label, multicenter trial in adults with primary refractory LBCL or relapse within twelve months of achieving complete response (CR) to first-line therapy. Participants had not yet received treatment for relapsed or refractory lymphoma and were potential candidates for autologous HSCT. A total of 184 participants were randomized 1:1 to receive a single infusion of lisocabtagene maraleucel following fludarabine and cyclophosphamide lymphodepleting chemotherapy or to receive second-line standard therapy, consisting of three cycles of chemoimmunotherapy followed by high-dose therapy and autologous HSCT in participants who attained CR or partial response (PR).Efficacy was also evaluated in PILOT (NCT03483103), a single-arm, open-label, multicenter trial in transplant-ineligible patients with relapsed or refractory LBCL after one line of chemoimmunotherapy. The study enrolled participants who were ineligible for high-dose therapy and HSCT due to organ function or age, but who had adequate organ function for CAR-T cell therapy. Efficacy was based on CR rate and duration of response (DOR) as determined by an IRC. Of 74 participants who underwent leukapheresis (median age, 73 years), 61 (82%) received lisocabtagene maraleucel of whom 54% (95% CI: 41, 67) achieved CR. The median DOR was not reached (95% CI: 11.2 months, not reached) in participants who achieved CR and 2.1 months (95% CI: 1.4, 2.3) in participants with a best response of PR. Among all leukapheresed participants, the CR rate was 46% (95% CI: 34, 58).
In humans, a single transverse palmar crease is a single crease that extends across the palm of the hand, formed by the fusion of the two palmar creases (known in palmistry as the "heart line" and the "head line"). Although it is found more frequently in persons with several abnormal medical conditions, it is not predictive of any of these conditions since it is also found in perfectly healthy persons. It is found in 1.5% of the world population in at least one hand. Former name
Because it resembles the usual condition of non-human simians, it was, in the past, called the simian crease or simian line. These terms have widely fallen out of favor due to their pejorative connotation. Medical significance
The presence of a single transverse palmar crease has no medical significance. It is found in 1.5% of all people, and though it is found at a higher frequency in people with abnormal medical conditions, in every one of these conditions many people do not have a single transverse palmer crease, thus it has low predictive value. Males are twice as likely as females to have this characteristic, and it tends to run in families.