GSK Reports Health Canada’s NDS Acceptance of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP

Shots: Health Canada has accepted NDS of depemokimab as an adjunctive therapy for asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as inadequately controlled CRSwNP based on P-III (SWIFT & ANCHOR) trials, respectively SWIFT-1 (n=382) & SWIFT-2 (n=380) trials assessed depemokimab vs PBO + SoC, ICS & controller…

ByRidhi RastogiMay 27, 2025

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Genentech Reports P-III (STARGLO) Trial Data on Columvi for R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Shots: Genentech has reported 2yr. P-III (STARGLO) trial data assessing Columvi + GemOx vs Rituxan + GemOx in previously treated ASCT-ineligible r/r DLBCL pts At 24.7mos. mFU, trial showed a 40% improvement in OS (mOS: not reached vs 13.5mos.), a 59% reduction in risk of progression or death, & CRs in 58.5% vs 25.3% pts;…

ByRidhi RastogiMay 26, 2025

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Roche’s Itovebi Regimen Secures the CHMP’s Positive Opinion for PIK3CA-mutated Breast Cancer

Shots: The CHMP has recommended Itovebi + Ibrance & fulvestrant as a 1L therapy for adults with PIK3CA-mutated, HR+/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, improved PFS (1EP) by…

ByRidhi RastogiMay 26, 2025

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Gilead Reports Topline P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC)

Shots: Gilead has reported topline P-III (ASCENT-03) trial data (n=~540) assessing Trodelvy vs CT in 1L pts with locally advanced, inoperable, or metastatic TNBC without PD-L1 expression or PD-L1+ pts who are previously treated with a PD-L1 inhibitor Trial met its 1EP of improved PFS in treatment-naïve mTNBC pts ineligible for PD-1/PD-L1 inhibitors; OS (2EP) data…

ByRidhi RastogiMay 26, 2025

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GSK Receives the CHMP’s Positive Opinion for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

S Shots: CHMP recommended Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; EC decision expected in Q3’25. Review ongoing in the US (PDUFA: Jul 23, 2025), Canada, China (PR for DREAMM-7), & Switzerland (PR for DREAMM-8) Opinion was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494…

ByRidhi RastogiMay 26, 2025

NEWS

The US FDA Approves Arcutis Biotherapeutics’ Zoryve Topical Foam for Plaque Psoriasis

Shots: FDA has approved sNDA of Zoryve (0.3% roflumilast) for pts (≥12yrs.) with plaque PsO of scalp & body based on P-III (ARRECTOR) & P-II (Trial 204) trials assessing it vs vehicle in 736 pts for 8wks. ARRECTOR met its co-1EPs, with 66.4% vs 27.8% pts achieving Scalp-IGA success & 45.5% vs 20.1% pts attaining…

ByRidhi RastogiMay 23, 2025

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Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Retinopathy

Shots: The US FDA has approved Susvimo (port delivery platform with Lucentis) for the treatment of diabetic retinopathy (DR) Approval was based on 1 yr. P-III (Pavilion) trial data assessing Susvimo (100mg/mL, refilled Q9M) vs monthly clinical observation in 173 pts with non-proliferative DR without center-involved DME, where subjects in Susvimo arm received 2 loading…

ByRidhi RastogiMay 23, 2025

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GSK Reports the US FDA’s Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The US FDA has approved Nucala as an add-on treatment for inadequately controlled COPD & eosinophilic phenotype based on the P-III (MATINEE & METREX) trial; EMA & NMPA’s submissions are under review MATINEE assessed Nucala (n=403; 100mg, SC, Q4W) vs PBO (n=401) in COPD pts (n=804) with type 2 inflammation while METREX evaluated it…

ByRidhi RastogiMay 23, 2025

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AstraZeneca’s Tagrisso (Osimertinib) Secures Health Canada’s Conditional Approval to Treat Unresectable EGFR-Mutated NSCLC

Shots: Health Canada has granted conditional approval to Tagrisso for the treatment of pts with locally advanced, inoperable NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, whose disease progressed on or following Pt-based CRT Approval was based on P-III (LAURA) study assessing Tagrisso (80mg, QD, PO) vs PBO among adults (n=216)…

ByRidhi RastogiMay 22, 2025

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Pfizer Enters a ~$6.05B Exclusive Licensing Agreement with 3SBio for SSGJ-707

Shots: 3SBio & its subsidiaries will grant Pfizer exclusive license to develop, manufacture & market SSGJ-707 worldwide, excl. China, with an option to obtain marketing rights in China As per the deal, 3SBio will receive $1.25B upfront & ~$4.8B in development, regulatory & commercial milestones, plus double-digit tiered royalties on SSGJ-707 sales; closing is expected…

ByRidhi RastogiMay 20, 2025

GSK Reports Health Canada’s NDS Acceptance of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP

Genentech Reports P-III (STARGLO) Trial Data on Columvi for R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Roche’s Itovebi Regimen Secures the CHMP’s Positive Opinion for PIK3CA-mutated Breast Cancer

Gilead Reports Topline P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC)

GSK Receives the CHMP’s Positive Opinion for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

The US FDA Approves Arcutis Biotherapeutics’ Zoryve Topical Foam for Plaque Psoriasis

Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Retinopathy

GSK Reports the US FDA’s Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

AstraZeneca’s Tagrisso (Osimertinib) Secures Health Canada’s Conditional Approval to Treat Unresectable EGFR-Mutated NSCLC

Pfizer Enters a ~$6.05B Exclusive Licensing Agreement with 3SBio for SSGJ-707

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