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The EC has granted ODD to ABO-101 for the treatment of primary hyperoxaluria
ABO-101 is being evaluated in an open-label global P-I/II (redePHine) study assessing safety, tolerability, PK/PD, & preliminary efficacy of a single dose of ABO-101 in pts with PH type 1
ABO-101 is a one-time, liver-directed gene-editing therapy that uses an Acuitas-licensed…
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The US FDA has approved Tryngolza (olezarsen; 50 or 80mg, QM) as an adjunct to diet to reduce triglycerides (TG) & the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG); commercially available in Jul 2026
Approval was based on the P-III (CORE: n=617 & CORE2: n=446) trials assessing Tryngolza (SC) vs PBO…
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The US FDA has approved Trodelvy + Keytruda/Keytruda Qlex for the 1L treatment of adults with inoperable, locally advanced, or metastatic TNBC expressing PD-L1 (CPS ≥ 10)
Approval was based on the P-III (ASCENT-04/KEYNOTE-D19) trial assessing Trodelvy (10mg/kg, IV, Day 1 & 8 of each 21-day cycle) + Keytruda (200mg, IV, Day 1 of…
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The US FDA has approved Pfizer's Ibrance (palbociclib) + trastuzumab ± pertuzumab, & endocrine therapy for the maintenance treatment of adults with HR+, HER2+ locally advanced or metastatic breast cancer following induction treatment
Approval was based on the AFT-sponsored P-III (PATINA) trial, where pts receiving a median of 6 cycles of induction treatment were…
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The EC has approved Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for cisplatin-ineligible pts with resectable MIBC across all 30 EEA states
Approval was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (neoadj. & adj. Keytruda), Arm B (surgery alone), or Arm C (neoadj. & adj. Keytruda + Padcev)…
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The EC has approved Trodelvy monotx. as a 1L therapy for the treatment of adults with unresectable or metastatic TNBC who are ineligible for PD-1/PD-L1 inhibitor therapy across all 30 EEA states
Approval was backed by the P-III (ASCENT-03) trial showing a 38% reduced risk of disease progression or death in patients who are…
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The EC has approved Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with Familial Chylomicronemia Syndrome (FCS), backed by the P-III (PALISADE) trial assessing it (25 & 50mg, SC, Q3M) vs PBO in 75 FCS adults
Trial met its 1 & all multiplicity-controlled key 2EPs. 25mg showed an 80% vs…
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The EC has approved Cenrifki (PO, QD) for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses in the last 2yrs.
Approval was backed by P-III (HERCULES) trial (vs PBO) in non-relapsing SPMS (nrSPMS) & supporting data from P-III (GEMINI 1 & 2) studies (vs teriflunomide) in relapsing MS, with HERCULES demonstrating delayed…
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The MHLW has approved Sarclisa (isatuximab; SC) + SoC for MM, while regulatory filing for the CirCLIQ on-body injector (OBI), based on the enFuse platform & submitted by Enable Injections, is under review; filing for both OBI & SC manual injection is under FDA review
Approval was based on the P-III (IRAKLIA) study in R/R…
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The MHLW has approved Minjuvi (tafasitamab) + Lenalidomide for the treatment of adult pts. with r/r diffuse large B-cell lymphoma (DLBCL)
Approval was based on the international P-II (L-MIND) trial, & a Japanese P-Ib/II (J-MIND) trial (Group 6) assessing Minjuvi + lenalidomide in pts with r/r DLBCL who are not eligible for autologous stem…

