The EC Approves Daiichi Sankyo and AstraZeneca’s Enhertu for Previously Treated HER2+ Metastatic Solid Tumors

Shots: Enhertu approval for previously treated adults with unresectable or metastatic HER2+ (IHC 3+) solid tumors & no satisfactory treatment option, was based on subgroup data from P-II trials, incl. DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02. In DESTINY-PanTumor02, Enhertu achieved a cORR of 52.3% & mDOR of 21.1mos. in previously treated HER2+ solid tumors (n=111), while DESTINY-Lung01 reported a cORR of…

ByRidhi Rastogi4 hours ago

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Viridian Therapeutics Reports the US FDA Approval of Lumvoa (veligrotug-vvze) for Thyroid Eye Disease

Shots: The US FDA has approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED), with immediate launch planned across the US. Also, SC elegrobart BLA filing for TED on track for Q1’27 Approval was granted under FDA Priority Review & supported by the P-III THRIVE (active TED) & THRIVE-2 (chronic TED) trials, which…

ByRidhi Rastogi6 hours ago

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Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the CHMP Positive Opinion for Rett Syndrome

Shots: The CHMP has recommended Daybu (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in pts (≥5yrs.); If approved, authorization would be valid in all 30 EEA states Opinion was based on the results from the P-III (LAVENDER) study, which showed improvements in core features of Rett syndrome, as measured by RSBQ & CGI-I…

ByRidhi Rastogi10 hours ago

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Daiichi Sankyo and AstraZeneca Report the CHMP Positive Opinion for Datroway to Treat Metastatic Triple Negative Breast Cancer

Shots: The CHMP has recommended Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy; regulatory review is ongoing in China & Japan, as well as Australia, Canada, Singapore & Switzerland as part of Project Orbis Opinion was backed by the global P-III (TROPION-Breast02)…

ByRidhi Rastogi3 days ago

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Everest Medicines Reports NMPA’s BLA Acceptance of Lerochol for Hypercholesterolemia

Shots: The NMPA has accepted BLA of Everest's Lerochol (lerodalcibep; SC, QM) as an adjunct to diet & exercise to reduce LDL-C in adults with hypercholesterolemia, incl. heterozygous familial hypercholesterolemia; regulatory review is ongoing in the EU The BLA was supported by multiple global trials & a P-III China study, where in global trials, Lerochol…

ByRidhi Rastogi3 days ago

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Chiesi Group and Arbor Biotechnologies Secure the EC’s Orphan Drug Designation for ABO-101 to Treat Primary Hyperoxaluria

Shots: 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…

ByRidhi Rastogi3 days ago

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Ionis’ Tryngolza Receives the US FDA Approval for Patients with Severe Hypertriglyceridemia

Shots: 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…

ByRidhi Rastogi3 days ago

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Merck and Gilead Report FDA Approval of Trodelvy + Keytruda for Previously Untreated PD-L1+ TNBC

Shots: 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…

ByRidhi Rastogi4 days ago

NEWS

Pfizer’s Ibrance Combination Receives FDA Approval as a Maintenance Therapy for HR+, HER2+ Metastatic Breast Cancer

Shots: 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…

ByRidhi Rastogi4 days ago

NEWS

Merck Receives EC Approval for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

Shots: 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)…

ByRidhi RastogiJune 24, 2026

The EC Approves Daiichi Sankyo and AstraZeneca’s Enhertu for Previously Treated HER2+ Metastatic Solid Tumors

Viridian Therapeutics Reports the US FDA Approval of Lumvoa (veligrotug-vvze) for Thyroid Eye Disease

Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the CHMP Positive Opinion for Rett Syndrome

Daiichi Sankyo and AstraZeneca Report the CHMP Positive Opinion for Datroway to Treat Metastatic Triple Negative Breast Cancer

Everest Medicines Reports NMPA’s BLA Acceptance of Lerochol for Hypercholesterolemia

Chiesi Group and Arbor Biotechnologies Secure the EC’s Orphan Drug Designation for ABO-101 to Treat Primary Hyperoxaluria

Ionis’ Tryngolza Receives the US FDA Approval for Patients with Severe Hypertriglyceridemia

Merck and Gilead Report FDA Approval of Trodelvy + Keytruda for Previously Untreated PD-L1+ TNBC

Pfizer’s Ibrance Combination Receives FDA Approval as a Maintenance Therapy for HR+, HER2+ Metastatic Breast Cancer

Merck Receives EC Approval for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

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