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 statesApproval 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

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 reviewApproval 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 AmericaAt 59mos. mFU, trial…

ByRidhi RastogiApril 8, 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 regionsTrial (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

Genmab and Pfizer Secure the EC’s Approval for Tivdak (Tisotumab Vedotin) for Recurrent or Metastatic Cervical Cancer

Shots:The EC has approved Tivdak an ADC, as a monotx. for adults (n=502) with recurrent or metastatic cervical cancer with disease progression on or after systemic therapyApproval was backed by P-III (innovaTV 301) global trial evaluating Tivdak vs CT alone (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)The trial met its 1EP of OS,…

ByDipanshu DixitApril 1, 2025

News

BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC

Shots:The CHMP has recommended Opdivo + Pt-based CT as neoadj. followed by Opdivo alone as adj. treatment of adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1%. If approved, EC’s decision would be valid in all 30 EEA statesThe P-III (CheckMate-77T) study assessed neoadj. Opdivo + CT, followed by surgery…

ByRidhi RastogiMarch 31, 2025

News

AstraZeneca Reports the EC’s Approval of Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Shots:The EC has approved Imfinzi monotx. for the treatment of LS-SCLC adults whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions Approval was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by…

ByRidhi RastogiMarch 17, 2025

News

Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

Shots:Celltrion has launched SteQeyma (ustekinumab-stba) injection, a biosimilar to Stelara, for all indications of the reference products following the US FDA’s approval in Dec 2024Approval was supported by various clinical evidence incl. P-III trial of SteQeyma vs Stelara for mod. to sev. plaque PsO, with 1EP as rate of change in the PASI for skin…

ByRidhi RastogiMarch 17, 2025

News

BMS Reports the EC’s Approval of Breyanzi to Treat R/R Follicular Lymphoma

Shots:The EC has approved Breyanzi for r/r follicular lymphoma adults treated with ≥2 previous lines of systemic therapy in 30 EEA states Approval was based on global P-II (TRANSCEND FL) study, assessing Breyanzi’s safety & efficacy to treat r/r indolent B-cell NHL incl. FL In pts treated in 3L+ setting, study met…

ByRidhi RastogiMarch 17, 2025

News

Otsuka and Lundbeck Receive the EC’s Approval for Rxulti to Treat Schizophrenia in Adolescents

Shots:The EC has approved Rxulti (brexpiprazole) to treat schizophrenia in pts (≥13yrs.) following CHMP’s positive opinion in Jan 2025 Approval was based on P-III trial assessing Rxulti (2 to 4mg/day, PO, QD) vs PBO vs Aripiprazole in adolescents (n=316) for 6wks. that showed greater reduction in symptom severity compared to PBO as measured by…

ByRidhi RastogiMarch 13, 2025

News

Geron Receives the EC’s Approval for Rytelo (Imetelstat) to Treat Transfusion-Dependent Anemia due to Lower-Risk MDS

Shots:The EC has approved Rytelo to treat TD anemia in adults with very low, low, or intermediate risk non-del(5q) MDS, unresponsive or ineligible for erythropoietin-based therapy in 30 EEA states; commercialization to begin in select EU states by 2026 pending country-by-country reimbursement Approval was based on P-III (IMerge) study of Rytelo vs PBO…

ByRidhi RastogiMarch 12, 2025

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

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

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

Genmab and Pfizer Secure the EC’s Approval for Tivdak (Tisotumab Vedotin) for Recurrent or Metastatic Cervical Cancer

BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC

AstraZeneca Reports the EC’s Approval of Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

BMS Reports the EC’s Approval of Breyanzi to Treat R/R Follicular Lymphoma

Otsuka and Lundbeck Receive the EC’s Approval for Rxulti to Treat Schizophrenia in Adolescents

Geron Receives the EC’s Approval for Rytelo (Imetelstat) to Treat Transfusion-Dependent Anemia due to Lower-Risk MDS

Contact US

OUR INFORMATION

FOLLW US

FOLLW US

Sign Up to Our Newsletter