This Oncology video recap covering news from the last thre weeks brings together major regulatory decisions, first-line treatment approvals, and strategic pipeline moves shaping cancer care.
🎯 Watch Our Video Summary Capturing Oncology News from the Last Three Weeks
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Top Stories Covered in This Video
Chapters
0:00 Introduction
0:08 FDA approves subcutaneous Rybrevant FASPRO for all amivantamab indications, enabling 5-minute dosing in EGFR-mutated NSCLC
0:50 Enhertu plus pertuzumab wins US first-line approval in HER2-positive metastatic breast cancer with PFS gain over THP
1:15 EMA validates Datroway, datopotamab deruxtecan, Type II variation for first-line TNBC not eligible for immunotherapy
1:43 EMA backs Phase 3 design for VCN-01 plus gemcitabine and nab-paclitaxel in first-line metastatic PDAC with OS primary endpoint
2:19 Canada’s CDA recommends Opdivo plus Yervoy for first-line MSI-H/dMMR mCRC, Ontario lists via FAST program 2:44 British Columbia to reimburse Fruzaqla, fruquintinib, for previously treated metastatic colorectal cancer
3:10 FDA grants Breakthrough Therapy Designation to JSKN003 for HER2-expressing platinum-resistant ovarian cancer after bevacizumab
3:38 FDA converts rucaparib to regular approval for BRCA-mutated mCRPC after ARPI based on TRITON3 rPFS benefit 4:09 Japan approves Zynyz, retifanlimab, plus carboplatin and paclitaxel for first-line advanced squamous cell anal carcinoma, 37 percent PFS risk reduction
4:33 Johnson and Johnson completes 3.05-billion-dollar Halda Therapeutics acquisition, adding RIPTAC platform and HLD-0915
4:57 How to reach us
Transcript
Welcome to the latest edition of Oncology Updates, covering breakthroughs in the past three weeks. Brought to you by LucidQuest.
Johnson and Johnson reports FDA approval of subcutaneous Rybrevant FASPRO, amivantamab with hyaluronidase-lpuj, across all Rybrevant indications. This enables about five-minute dosing and fewer administration-related reactions versus intravenous, with PK co-primary endpoints met in PALOMA 3. MARIPOSA showed an overall survival advantage for amivantamab plus lazertinib over osimertinib in first-line EGFR exon 19 deletion and L858R non-small cell lung cancer, supporting early combination use.
AstraZeneca and Daiichi Sankyo received US approval for Enhertu plus pertuzumab in first-line her 2 -positive metastatic breast cancer. In DESTINY-Breast09 the combination improved progression-free survival over THP, with median progression-free survival over three years and safety consistent with known profiles.
The EMA validated the Datroway type II variation for datopotamab deruxtecan monotherapy as first-line treatment for metastatic triple-negative breast cancer in patients not candidates for PD-1 or PD-L1 therapy. The filing is based on TROPION-Breast02, which showed significant overall survival and progression-free survival benefit versus chemotherapy.
Theriva Biologics received positive EMA scientific advice for a double-blind, placebo-controlled Phase 3 of VCN-01 plus gemcitabine and nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma. The agency endorsed an overall survival primary endpoint, an adaptive design, and dosing macrocycles, reflecting VIRAGE Phase 2b signals in overall survival, progression-free survival, and duration of response.
In Canada the Canadian Drug Agency issued a positive reimbursement recommendation for Opdivo plus Yervoy in first-line MSI-H or dMMR metastatic colorectal cancer based on a progression-free survival advantage in CheckMate-8HW. Ontario listed the regimen via the FAST program, with provincial criteria.
British Columbia will reimburse Fruzaqla, fruquintinib, for adults with previously treated metastatic colorectal cancer who have received or are unsuitable for standard therapies. This follows Health Canada authorization in September 2024 and is supported by FRESCO-2 and FRESCO data showing overall survival and progression-free survival benefits.
The FDA granted Breakthrough Therapy Designation to JSKN003, a biparatopic her 2 -directed antibody-drug conjugate, for platinum-resistant ovarian cancer after bevacizumab. The decision is based on pooled Phase 1 and Phase 2 data, with additional China designations and US fast-track and orphan designations noted.
The FDA converted rucaparib to regular approval for adults with BRCA-mutated metastatic castration-resistant prostate cancer after an androgen receptor pathway inhibitor. Approval is supported by TRITON3, which showed a radiographic progression-free survival benefit versus physician-choice therapy, while overall survival was not significant and ATM subgroup exploratory results did not drive benefit.
In Japan the health ministry approved Zynyz, retifanlimab, with carboplatin and paclitaxel as first-line therapy for advanced squamous cell anal carcinoma. POD1UM-303 and InterAACT2 showed a 37 percent reduction in risk of progression or death, and serious adverse reactions in 47 percent with the combination.
Johnson and Johnson completed its 3.05 billion-dollar acquisition of Halda Therapeutics, adding HLD-0915 for prostate cancer and the RIPTAC regulated induced proximity platform. The company highlighted potential to overcome resistance and extend beyond oncology, with expected EPS dilution.
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Why It Matters
- Several first-line approvals and access moves may influence prescriber choice and payer reviews pending full data.
- New SC route for amivantamab could expand screening, initiation, and follow-up at scale.
- Regulatory validations and scientific advice in TNBC and PDAC signal near-term readouts that could inform practice and payer discussions.
- BD activity in targeted protein proximity platforms signals modality expansion.
🗓️ Explore weekly details and sources
📚 See the full Oncology archive on our research hub page.
FAQ
What does FDA’s Rybrevant FASPRO decision change for EGFR-mutated NSCLC?
It enables SC administration across all existing Rybrevant indications, potentially reducing administration time and reactions, with first-line use in combo with lazertinib already supported by MARIPOSA OS data [1].
How does Enhertu + pertuzumab compare to THP in 1L HER2+ mBC?
DESTINY-Breast09 showed a statistically significant PFS improvement and a median PFS over three years vs about 27 months with THP, supporting the US approval for the combo [2].
Who benefits from Datroway’s EMA-validated 1L TNBC filing?
Adults with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 therapy; filing is based on OS and PFS gains vs chemotherapy in TROPION-Breast02 [3].
What is EMA’s guidance on Theriva’s VCN-01 Phase 3 in PDAC?
A single, double-blind, placebo-controlled study with OS primary endpoint and adaptive design is acceptable if benefit-risk is compelling; repeated dosing macrocycles are endorsed [4].
What did Canada’s CDA recommend for mCRC, and who has access now?
CDA recommended Opdivo + Yervoy in 1L MSI-H/dMMR mCRC; Ontario listed it via the FAST program. BC also moved to reimburse Fruzaqla for previously treated mCRC under criteria [5][6].
What is the scope of FDA’s regular approval for rucaparib in mCRPC?
Adults with BRCAm mCRPC after ARPI, selected by an FDA-approved CDx, with rPFS benefit confirmed in TRITON3; OS not significant at this time [8].
Entities / Keywords
Rybrevant FASPRO (amivantamab and hyaluronidase-lpuj) • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • MARIPOSA • PALOMA-3 • Enhertu (trastuzumab deruxtecan) • Pertuzumab • DESTINY-Breast09 • Datroway (datopotamab deruxtecan, Dato-DXd) • TROPION-Breast02 • VCN-01 • VIRAGE • Opdivo (nivolumab) • Yervoy (ipilimumab) • CheckMate-8HW • Fruzaqla (fruquintinib) • JSKN003 (HER2 ADC) • Rucaparib (Rubraca) • TRITON3 • Zynyz (retifanlimab) • POD1UM-303/InterAACT2 • Halda Therapeutics • RIPTAC platform • Prostate cancer • EGFR-mutated NSCLC • HER2-positive breast cancer • TNBC • PDAC • mCRC • SCAC • PROC.