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FDA Grant Accelerated Approval for Genentech’s Bispecific Antibody, Columvi in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
FDA Grant Accelerated Approval for Genentech’s Bispecific Antibody, Columvi in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Accelerated approval based Phase I/II NP30179 study of Columvi given as a fixed course for 8.5 months in 132 patients with r/r DLBCL, including about 30% who had received prior CAR T-cell therapy; 83% were refractory to their most recent therapy
Results showed 56% of patients achieving an overall response, 43% achieving a complete response
Over two-thirds of those who responded continued to respond for at least nine months (68.5%)
FDA approves olaparib with abiraterone and prednisone (or prednisolone) for BRCA-mutated metastatic castration-resistant prostate cancer
FDA approves olaparib with abiraterone and prednisone (or prednisolone) for BRCA-mutated metastatic castration-resistant prostate cancer
FDA follows ODAC advice, approving the sNDA for the restricted indication of BRCA-mutated mCRPC
Exploratory subgroup analysis in 85 patients with BRCAm (11% of ITT population) demonstrated a median rPFS that was not reached in the olaparib with abiraterone arm compared to 8 months (95% CI: 6, 15) for those receiving placebo with abiraterone (HR 0.24)
OS HR in these patients was 0.30 (95% CI: 0.15, 0.59)
FDA Approves AYVAKIT (avapritinib) as the First and Only Treatment for Indolent Systemic Mastocytosis
FDA Approves AYVAKIT (avapritinib) as the First and Only Treatment for Indolent Systemic Mastocytosis
Efficacy was based on the absolute mean change from baseline to Week 24 in the Indolent Systemic Mastocytosis-Symptom Assessment Form (ISM-SAF) total symptom score (TSS)
AYVAKIT demonstrated significant improvements versus PBO in the primary and all key secondary endpoints, including overall symptoms and measures of mast cell burden
AYVAKIT was well-tolerated with a favorable safety profile compared to placebo, and most adverse reactions were mild to moderate in severity
FDA Approve EPKINLY™ (epcoritamab-bysp) as the First Bispecific Antibody to Treat Adults with r/r DLBCL
FDA Approve EPKINLY™ (epcoritamab-bysp) as the First Bispecific Antibody to Treat Adults with r/r DLBCL
EPKINLY monotherapy demonstrated responses in DLBCL patients who have received at least two prior treatments
Overall response (complete or partial response) was seen in 61% (90/148) of patients and 38% (56/148) achieved complete remission
Median DOR was 15.6 months (95 percent CI: 9.7-Not reached)
Servier receives EU approval of Tibsovo® in IDH1-mutated AML and IDH1-mutated Cholangiocarcinoma
Servier receives EU approval of Tibsovo® in IDH1-mutated AML and IDH1-mutated Cholangiocarcinoma
In AML, a statistically significant improvement in EFS HR 0.33; & OS HR 0.44 was seen in patients treated with Tibsovo® in combination with AZA vs. AZA + PBO
In cholangiocarcinoma, a statistically significant improvement in PFS HR 0.37 was observed; mPFS for Tibsovo® and placebo was 2.7 and 1.4 months, respectively
European Commission Approves BMS CAR T Breyanzi r/r Large B-cell Lymphoma After One Prior Therapy
European Commission Approves BMS CAR T Breyanzi r/r Large B-cell Lymphoma After One Prior Therapy
Breyanzi more than quadrupled median EFS compared to standard therapy (10.1 months vs. 2.3 months [HR: 0.349; 95% CI (0.229-0.530) p<0.0001]) at an interim analysis with a median follow-up of 6.2 months
Results of the primary analysis, with a median follow-up of 17.5 months were consistent with the interim analysis, with median EFS not reached for Breyanzi (95% CI: 9.5-NR) vs. 2.4 months for standard therapy (95% CI: 2.2-4.9)
FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma
FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma
ORR in 121 patients was 68% (95% CI: 59, 76), including 12% with complete responses
mDOR for the dose escalation cohort + Cohort A was 22 months (range: 1+ to 46+) and for Cohort K was not reached (range: 1 to 24+)
This application was granted priority review and breakthrough designation
FDA approves dabrafenib with trametinib for pediatric patients with low-grade glioma with a BRAF V600E mutation
FDA approves dabrafenib with trametinib for pediatric patients with low-grade glioma with a BRAF V600E mutation
This represents the first FDA approval of a systemic therapy for the first-line treatment of pediatric patients with LGG with a BRAF V600E mutation
ORR 46.6% in the D+T arm and 10.8% for those receiving C+V (p= <0.001). DOR was 23.7 months (95% CI: 14.5, not estimable) in the D+T arm and not estimable (95% CI: 6.6, not estimable) in the C+V arm