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NEWS

Daiichi Sankyo and Merck Dose First Patient in P-III (HERTHENA-Breast04) Trial of Patritumab Deruxtecan to Treat HR+/HER2- Breast Cancer

Shots:The first patient is dosed in P-III (HERTHENA-Breast04) trial (n=~1000) of patritumab deruxtecan (HER3-DXd; 5.6mg/kg) vs CT/Enhertu for unresectable LA/M, HR+, HER2- breast cancer after progression on endocrine & CDK4/6 inhibitor therapy in either adjuvant or 1L metastatic settingsHERTHENA-Breast04 was initiated based on findings from P-II (ICARUS-Breast01) & a P-I/II breast cancer study published…
August 28, 2025

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Daiichi Sankyo
NEWS

Daiichi Sankyo’s Datroway (Datopotamab Deruxtecan) Receives the NMPA’s Approval for Unresectable or Recurrent HR+/HER2- Breast Cancer

Shots:China’s NMPA has approved Datroway for treating adults with HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) inoperable or recurrent breast cancer after previous CTApproval was based on P-III (TROPION-Breast01) study assessing Datroway (6mg/kg, IV, Q21D) vs single-agent CT in adults (n=732) with HR+/HER2- metastatic breast cancerStudy showed improved PFS by 37%…
August 25, 2025

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

Shots:Health Canada has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC ptsApproval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT vs PBO + ADT in 669 mHSPC ptsTrial showed a 46% reduction in rPFS (1EP), with consistent benefit observed across all subgroups, incl. pts…
August 22, 2025

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NEWS

Health Canada Grants Conditional Approval to Iovance’s Amtagvi (Lifileucel) for Advanced Melanoma

Shots:Health Canada has granted conditional approval (NOC/c) to Amtagvi for adults with unresectable or metastatic melanoma progressing after prior systemic therapy, incl. PD-1 inhibitor &, if BRAF V600 positive, then BRAF ± MEK inhibitor, with no suitable alternative optionsApproval was granted based on global P-II (C-144-01) trial assessing Amtagvi in above pts, which…
August 20, 2025

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NEWS

Dizal Receives the US FDA’s Accelerated Approval for Zegfrovy (Sunvozertinib) to Treat EGFRm NSCLC

Shots:The US FDA has granted accelerated approval to Zegfrovy for locally advanced or metastatic NSCLC associated with EGFR exon 20 insertion mutations (exon20ins) in pts whose disease has progressed on or after Pt-based CTApproval was based on the multinational WU-KONG1 part B trial assessing Zegfrovy in above mentioned pts, which showed significant improvement…
July 3, 2025

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Astrazeneca
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AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the EC’s Approval for 1L Mantle Cell Lymphoma (MCL)

Shots:The EC has approved Calquence + bendamustine & rituximab for the treatment of ASCT-ineligible pts with previously untreated MCL; regulatory review is ongoing in Japan & other regionsApproval was based on P-III (ECHO) trial assessing the combination vs SoC (bendamustine & rituximab) in 1L MCL pts (≥65yrs.; n=635), which showed improved PFS of 27%,…
May 8, 2025

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Bayar
NEWS

Bayer Reports Post-Hoc Data from P-III (ARANOTE) Trial of Nubeqa to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots:Bayer has reported post-hoc analyses from P-III (ARANOTE) trial assessing Nubeqa (darolutamide; 600mg, BID) + androgen deprivation therapy (ADT) (n=446) vs PBO + ADT (n=223) in mHSPC pts (N=669)Post-hoc analyses showed that 42.6% pts achieved ultra-low PSA levels (<0.02ng/mL) vs 7.8% pts on PBO & this response was associated with prolonged rPFS, delayed…
April 30, 2025

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