BMS Reports the US FDA’s Approval of Opdivo + Yervoy as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)

Shots: The US FDA has approved Opdivo + Yervoy for 1L treatment of MSI-H/dMMR unresectable mCRC pts (≥12yrs.) based on P-III (CheckMate-8HW) study assessing Opdivo + Yervoy vs Opdivo alone or CT in 839 pts (Approved before PDUFA: Jun 23, 2025) Regimen vs Opdivo monotx. showed 38% PFS (mPFS: not reached (NR) vs 39.3mos) in…

ByRidhi RastogiApril 9, 2025

NEWS

The EC Approves AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults

Shots: The EC has approved Rinvoq (15mg; QD) to treat adults with giant cell arteritis (GCA) in 30 EEA states Approval was based on P-III (SELECT-GCA) trial assessing Rinvoq, where GCA pts (n=428) in first study period received either Rinvoq (7.5 or 15mg, QD) + 26wk. corticosteroid (CS) taper regimen or PBO + 52wk. CS taper regimen…

ByRidhi RastogiApril 8, 2025

NEWS

Rhythm Pharmaceuticals Reports Topline Data from P-III (TRANSCEND) Trial of Setmelanotide for Acquired Hypothalamic Obesity

Shots: The P-III (TRANSCEND) trial (N=120) assessed setmelanotide (n=81: 33 adults & 48 pediatric) vs PBO (n= 39) for acquired hypothalamic obesity in 49 adults & 71 pediatric pts; additional arm of 12 Japanese pts is ongoing, with topline data expected by Q1’26. FDA & EMA filings to be completed by Q3’25 Trial met its…

ByRidhi RastogiApril 8, 2025

NEWS

Teva Pharmaceuticals Reports the US FDA’s sBLA Acceptance of Ajovy (Fremanezumab) for Pediatric Episodic Migraine Prevention

Shots: The US FDA has accepted sBLA of Ajovy to prevent episodic migraine in children & adolescents (6-17yrs.; ≥45Kg) Submission was based on P-III (SPACE) trial assessing Ajovy (SC) vs PBO for 12wks. to treat episodic migraine in 237 pediatric pts, which showed improvements in reducing monthly migraine & headache days Ajovy (CGRP antagonist) is…

ByRidhi RastogiApril 8, 2025

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Johnson & Johnson Receives the EC’s Approval for Darzalex Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The EC has approved Darzalex (SC) + bortezomib, lenalidomide & dexamethasone (D-VRd) to treat NDMM pts; sBLA under the US FDA’s review Approval was based on P-III (CEPHEUS) trial assessing D-VRd (n=197) vs VRd (n=198) in 395 ASCT-ineligible or deferred pts, in 13 countries across the EU, North & South America At 59mos. mFU, trial…

ByRidhi RastogiApril 8, 2025

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Intellia Therapeutics Reports the First Patient Dosing in P-III (MAGNITUDE-2) Trial of Nexiguran Ziclumeran for ATTRv-PN

Shots: Intellia has reported the first pts dosing in its P-III (MAGNITUDE-2) trial assessing nexiguran ziclumeran (nex-z) for hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN); BLA submission is expected in 2028 Trial will assess nex-z (55mg infusion) vs PBO in ~50 ATTRv-PN pts to evaluate modified neuropathy impairment score & change in serum TTR levels as…

ByRidhi RastogiApril 7, 2025

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AstraZeneca Reports the EC’s Approval of Imfinzi Regimen as Perioperative Treatment of NSCLC

Shots: The EC has approved perioperative Imfinzi regimen to treat resectable NSCLC adults at high risk of recurrence & no EGFR mutations or ALK rearrangements; MAA under PMDA review Approval was based on P-III (AEGEAN) trial assessing neoadj. Imfinzi (1500mg; Q3W × 4 cycles) + CT followed by adj. Imfinzi alone (Q4W × ~12 cycles)…

ByRidhi RastogiApril 4, 2025

NEWS

Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots: The EC has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy, based on the P-III (DESTINY-Breast06) trial; regulatory review is ongoing in Japan & other regions Trial (N=866) assessed Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=153) pts, showing 38% PFS in CT-naïve…

ByRidhi RastogiApril 4, 2025

NEWS

Amgen’s Uplizna Receives the US FDA’s Approval for Immunoglobulin G4-related Disease (IgG4-RD)

Shots: The US FDA has approved Uplizna to treat adults with IgG4-RD; regulatory filings for gMG are underway, with completion expected in H1’25 Approval was based on P-III (MITIGATE) trial assessing Uplizna (n=68) vs PBO (n=67) in IgG4-RD adults, which incl. an optional 3yr. OLE & up to 2yrs. of safety follow-up after Uplinza discontinuation Trial…

ByRidhi RastogiApril 4, 2025

NEWS

Novartis’ Vanrafia (Atrasentan) Receives the US FDA’s Accelerated Approval for Primary IgA Nephropathy (IgAN)

Shots: The US FDA has granted accelerated approval to Vanrafia for proteinuria reduction in adults with primary IgAN at risk of rapid disease progression based on the ongoing P-III (ALIGN) trial, with no requirement for REMS program; traditional approval will be supported by eGFR results expected in 2026 Trial assessed atrasentan (0.75mg, PO, QD) +…

ByDipanshu DixitApril 3, 2025

BMS Reports the US FDA’s Approval of Opdivo + Yervoy as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)

The EC Approves AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults

Rhythm Pharmaceuticals Reports Topline Data from P-III (TRANSCEND) Trial of Setmelanotide for Acquired Hypothalamic Obesity

Teva Pharmaceuticals Reports the US FDA’s sBLA Acceptance of Ajovy (Fremanezumab) for Pediatric Episodic Migraine Prevention

Johnson & Johnson Receives the EC’s Approval for Darzalex Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Intellia Therapeutics Reports the First Patient Dosing in P-III (MAGNITUDE-2) Trial of Nexiguran Ziclumeran for ATTRv-PN

AstraZeneca Reports the EC’s Approval of Imfinzi Regimen as Perioperative Treatment of NSCLC

Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Amgen’s Uplizna Receives the US FDA’s Approval for Immunoglobulin G4-related Disease (IgG4-RD)

Novartis’ Vanrafia (Atrasentan) Receives the US FDA’s Accelerated Approval for Primary IgA Nephropathy (IgAN)

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