Servier Reports the CHMP’s Positive Opinion Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma

Shots: The CHMP has recommended to Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery but do not currently require radiotherapy or CT; anticipated EC decision in all 30 EEA states The CHMP opinion is based on the global P-III (INDIGO) trial (N=331), which included…

ByDipanshu DixitJuly 24, 2025

NEWS

GSK Receives Health Canada’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: Health Canada has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494 pts & Blenrep + PomDex (BPd) vs Velcade + PomDex in 302 pts, respectively DREAMM-7 showed improved PFS (1EP; mPFS: 36.6 vs 13.4mos.),…

ByDipanshu DixitJuly 24, 2025

NEWS

Johnson & Johnson’s Darzalex Secures the EC’s Approval for High-Risk Smouldering Multiple Myeloma

Shots: The EC has approved Darzalex SC (daratumumab) for the treatment of adults with high‑risk smouldering multiple myeloma (SMM) Approval was based on the P-III (AQUILA) study data assessing Darzalex SC monotx. vs active monitoring in high-risk SMM pts (n=390) At a mFU of 65.2mos., trial showed improved PFS, with 63.1% vs 40.8% pts alive…

ByRidhi RastogiJuly 24, 2025

NEWS

Johnson & Johnson’s Imbruvica Receives the EC’s Approval for Previously Untreated Mantle Cell Lymphoma (MCL)

Shots: The EC has approved a label extension for Imbruvica (ibrutinib) + R-CHOP alternating with R-DHAP (without ibrutinib), followed by ibrutinib monotx., for the treatment of previously untreated MCL pts ineligible for ASCT Approval was based on ongoing P-III (TRIANGLE) trial in 870 EU pts, assessing ibrutinib + chemoimmunotherapy (CIT) ± ASCT & 2yr. ibrutinib…

ByRidhi RastogiJuly 23, 2025

NEWS

Roche’s Itovebi Regimen Secures the EC’s Approval for PIK3CA-mutated Breast Cancer

Shots: The EC has approved Itovebi + Ibrance & fulvestrant as a 1L therapy for adults with PIK3CA-mutated, ER+/HER2- locally advanced or metastatic breast cancer recurring on or within 12mos. of adj. endocrine therapy, based on the P-III (INAVO120) trial Trial (n=325) assessed the regimen vs PBO + Ibrance & fulvestrant, which showed improved PFS…

ByRidhi RastogiJuly 23, 2025

NEWS

Merck’s Keytruda Regimen Receives Health Canada’s Approval for FIGO 2014 Stage III-IVA Cervical Cancer

Shots: Health Canada has approved Keytruda + chemoradiotherapy (CRT) for the treatment of adults with FIGO 2014 Stage III-IVA cervical cancer Approval was based on P-III (KEYNOTE-A18/ ENGOT-cx11/GOG-3047) trial assessing Keytruda (200mg, IV, Q3W × 5 cycles) + CRT followed by Keytruda (400mg, IV, Q6W × 15 cycles) vs PBO + CRT in 1060 pts with…

ByRidhi RastogiJuly 22, 2025

NEWS

Bavarian Nordic Reports the Health Canada’s NDS Acceptance of CHIKV VLP to Prevent Chikungunya

Shots: Health Canada has accepted NDS of CHIKV VLP for active immunization against CHIKV disease in individuals (≥12yrs.); decision is anticipated in H1’26 NDS was based on 2 P-III trials (n>3,500) that met their 1EP, with 97.8% of subjects aged 12–64yrs. & 87.3% aged >65yrs. developing neutralizing antibodies by day 21 post vaccination; seroresponse rates…

ByRidhi RastogiJuly 22, 2025

NEWS

Johnson & Johnson Submits NDA to the US FDA for Icotrokinra to Treat Plaque Psoriasis (PsO)

Shots: The US FDA has received NDA of icotrokinra for the treatment of pts (≥12yrs.) with mod. to sev. plaque PsO NDA was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where ICONIC-LEAD (vs PBO) met its co-1EPs of IGA 0/1 & PASI 90 at Wk. 16, plus showed higher rates of clear or almost clear…

ByRidhi RastogiJuly 22, 2025

NEWS

Bayer Reports EC’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The EC has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT vs PBO + ADT in 669 mHSPC pts Trial showed a 46% reduction in rPFS (1EP), with consistent benefit observed across all subgroups, incl. pts…

ByRidhi RastogiJuly 21, 2025

NEWS

Autolus Therapeutics’ Aucatzyl Secures the EC’s Approval for R/R B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Shots: The EC has approved Aucatzyl (Obecabtagene Autoleucel) for treating pts (≥26yrs.) with r/r B-ALL in all 30 EEA states The EC approval was based on the FELIX study (n=100+), which showed that pts in cohort IIA (n=94) receiving ≥1 infusion of obe-cel had a 76.6% CR/CRi rate, with a mDoR of 21.2mos. & mEFS…

ByDipanshu DixitJuly 21, 2025

Servier Reports the CHMP’s Positive Opinion Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma

GSK Receives Health Canada’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Johnson & Johnson’s Darzalex Secures the EC’s Approval for High-Risk Smouldering Multiple Myeloma

Johnson & Johnson’s Imbruvica Receives the EC’s Approval for Previously Untreated Mantle Cell Lymphoma (MCL)

Roche’s Itovebi Regimen Secures the EC’s Approval for PIK3CA-mutated Breast Cancer

Merck’s Keytruda Regimen Receives Health Canada’s Approval for FIGO 2014 Stage III-IVA Cervical Cancer

Bavarian Nordic Reports the Health Canada’s NDS Acceptance of CHIKV VLP to Prevent Chikungunya

Johnson & Johnson Submits NDA to the US FDA for Icotrokinra to Treat Plaque Psoriasis (PsO)

Bayer Reports EC’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Autolus Therapeutics’ Aucatzyl Secures the EC’s Approval for R/R B-Cell Acute Lymphoblastic Leukemia (B-ALL)

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