Adult

Jazz Presents Results of Xywav (Oral Solution) in P-III Withdrawal Study for Adult Patients with Idiopathic Hypersomnia at AAN2021

Shots: The P-III withdrawal study involves assessing the efficacy and safety of Xywav (oral solution) vs PBO in a ratio (1:1) in adult patients with idiopathic hypersomnia. The study includes a titration and optimization period of up to 14wks. followed by a 2wks. open-label, SDP The study demonstrated a change in ESS score within 2wks., …

Jazz Presents Results of Xywav (Oral Solution) in P-III Withdrawal Study for Adult Patients with Idiopathic Hypersomnia at AAN2021 Read More »

Kite Reports Submission of sBLA to the US FDA for Tecartus in Adult Patients with R/R Acute Lymphoblastic Leukemia

Shots: The sBLA is based on data from the P- I/II ZUMA-3 trial in adult patients age ≥18 years old for the treatment of adult patients with r/r B-cell ALL The focus of the study is to evaluate the safety and efficacy in adult patients with r/r ALL If approved, Tecartus will be the 1st …

Kite Reports Submission of sBLA to the US FDA for Tecartus in Adult Patients with R/R Acute Lymphoblastic Leukemia Read More »

Novartis’ Kesimpta (ofatumumab) Receives the EC’s Approval for Adult Patients with Relapsing Multiple Sclerosis

Shots: The approval is based on P-III ASCLEPIOS I and II studies that involve assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, PO, qd) in 1,882 adults aged 18-55yrs. with a confirmed diagnosis of RMS The study demonstrated a reduction of annual relapses by over 50% and achieved >30% relative risk reduction of 3mos. confirmed …

Novartis’ Kesimpta (ofatumumab) Receives the EC’s Approval for Adult Patients with Relapsing Multiple Sclerosis Read More »

BMS and Acceleron’s Reblozyl (Luspatercept) Receives Health Canada Approval for Adult Patients With Myelodysplastic Syndromes

Shots: The approval is based on P-III MEDALIST study involves assessing ReblozyL vs PBO in a ratio (2:1) in adult patients with very low- to intermediate-risk MDS-RS requiring regular RBC transfusions (>2 RBC units/ 8 wks) The results showed transfusion independence for 8 wks or longer during the first 24 wks (38% vs. 13%) Reblozyl …

BMS and Acceleron’s Reblozyl (Luspatercept) Receives Health Canada Approval for Adult Patients With Myelodysplastic Syndromes Read More »

Aurinia Lupkynis (voclosporin) Receives US FDA’s Approval to Treat Adult Patients with Active Lupus Nephritis

Shots: The approval is based on the pivotal AURORA P-III study and AURA-LV P-II study involves assessing of Lupkynis + SoC in 533 patients to treat adult patients with LN The study demonstrated significantly improved renal response rates vs SoC, improved response rates in all parameters across immunologically-active classes, 50 % reduction in UPCR twice …

Aurinia Lupkynis (voclosporin) Receives US FDA’s Approval to Treat Adult Patients with Active Lupus Nephritis Read More »

Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases

Shots: The approval is based on trial assessing Riabni (375 mg/m2, IV) vs Rituxan once weekly for 4wks. followed by dosing @12wks. & 20wks. in 256 patients in a ratio (1:1) with grade 1, 2, or 3a follicular B-cell NHL & low tumor burden The WAC of Riabni will be 23.7% lower than the Rituxan …

Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases Read More »

Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin lymphoma

Shots: The P-II ZUMA-5 study involves assessing Yescarta (axicabtagene ciloleucel) in patients with r/r iNHL after at least 2L of systemic therapy. After a single infusion of Yescarta, 92% of patients responded, including 76% of patients achieving a CR @median follow-up of 17.5 mos., results presented at ASH The data supports the US FDA’s acceptance …

Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin lymphoma Read More »

Alnylam’s Oxlumo (lumasiran) Receives the US FDA’s Approval for Treatment of Primary Hyperoxaluria Type 1 in Pediatric and Adult Patients

Shots: The approval is based on P-III ILLUMINATE-A & -B trials. The studies demonstrating reductions in urinary oxalate and encourage safety and tolerability in pediatric and adult patients The ILLUMINATE-A showed that Oxlumo met its 1EP i.e. change in 24hrs. (65% vs 12%) compared to PBO, the study also achieved significant results for all 6 …

Alnylam’s Oxlumo (lumasiran) Receives the US FDA’s Approval for Treatment of Primary Hyperoxaluria Type 1 in Pediatric and Adult Patients Read More »

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma

Shots: The approval is based on P-III KEYNOTE-204 study assessing Keytruda (200mg, IV, q3w vs BV (1.8 mg/kg, IV, q3w) in 304 patients in a ratio (1:1) with r/r cHL after at least one multi-agent CT regimen Results: reduction in the risk of disease progression or death by 35%, median PFS (13.2mos. vs 3mos); ORR …

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma Read More »