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 in the US and will be available at a WAC of $716.80/ 100mg and $3,584.00/ 500mg single-dose vial
  • Riabni is a biosimilar to Rituxan, approved for the treatment of NHL, CLL, GPA, MPA and ill be made available in the US in Jan 2021

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Adweek

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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 of BLA and is currently under PR for r/r FL, MZL, after two or more prior lines of systemic therapy, with an anticipated PDUFA date as Mar 5, 2021
  • Yescarta is the first CAR T-cell therapy to be approved by the US FDA for patients with r/r large B-cell lymphoma after two or more lines of systemic therapy

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Seek Vector Logo

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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 tested 2EPs
  • In ILLUMINATE-B, Oxlumo demonstrated a 72% mean reduction in spot urinary oxalate: creatinine ratio from baseline to 6mos., reduction of oxalate as consistent across all three body wt. categories. Additionally, therapy demonstrated positive results across 2EPs, including additional measures of oxalate

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Bloomberg

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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 (66% vs 54%); DOR (20.7 mos. vs 13.8mos.). The approval is reviewed under the FDA’s Project Orbis
  • Ketruda is a humanized mAb that blocks the interaction between PD-1 and its ligands, PD-L1 & PD-L2 thus activating T lymphocytes that affect tumor cells & healthy cells. Additionally, the US FDA has approved an updated pediatric indication for refractory cHL or cHL that has relapsed after two or more lines of therapy

Click here ­to­ read full press release/ article | Ref: Business Wire | Image: Fortune

The post Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma first appeared on PharmaShots.