FDA approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) with androgen receptor pathway inhibitor therapy for PSMA-positive metastatic androgen-pathway-modulation-naïve or-sensitive prostate cancer. The recommended dose is 7.4 GBq every six weeks for up to six doses.
Key points
Dosage: 7.4 GBq (200 mCi) every six weeks for six doses, or until progression or toxicity.
Trial NCT04720157 showed hazard ratio 0.72 for radiographic progression-free survival (p = 0.002).
Sources
- Original post
- FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen recep - Linked page
- clin.larvol.com - Linked in the post
lirafugratinib FDA approval for FGFR2-positive cholangiocarcinoma
lirafugratinib received FDA approval for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements. The approval follows the REFOCUS trial (NCT04526106) showing a 46% objective response rate and median duration of response of 11.8 months. The recommended dose is 70 mg orally once daily. The drug carries warnings for ocular toxicity, hyperphosphatemia, soft tissue mineralization, and embryo-fetal toxicity.
Key points
FDA approval for lirafugratinib in FGFR2-positive cholangiocarcinoma.
REFOCUS trial reported ORR 46% (95% CI 36-55) and median DOR 11.8 months (95% CI 7.5-13.0).
Sources
- Original post
- FDA approves lirafugratinib for previously treated, unresectable, loca - Linked page
- clin.larvol.com - Linked in the post
sevabertinib accelerated approval for HER2-mutated NSCLC
sevabertinib (Hyrnuo) received FDA accelerated approval on September 9 2026 for adult patients with locally advanced or metastatic non-squamous NSCLC harboring HER2 (ERBB2) TKD activating mutations. In the SOHO-01 trial, 69 treatment-naïve patients showed a 75% confirmed objective response rate, with 73% of responders maintaining response ≥6 months.
Key points
FDA granted accelerated approval to sevabertinib for HER2-mutated non-squamous NSCLC on September 9 2026.
In trial NCT05099172, the confirmed ORR was 75% (95% CI 64-85) among 69 patients.
Sources
- Original post
- FDA grants accelerated approval to sevabertinib for locally advanced o - Linked page
- clin.larvol.com - Linked in the post
Iberdomide accelerated approval with daratumumab
Iberdomide (Zenbexus) received FDA accelerated approval with daratumumab, hyaluronidase-fihj and dexamethasone for adults with relapsed or refractory multiple myeloma who have had at least one prior therapy. In the EXCALIBER-RRMM trial the MRD-negative complete response rate was 41% versus 21% for the comparator.
Key points
FDA granted accelerated approval on August 13 2026.
MRD-negative complete response rate: 41% (IberDd) vs 21% (DVd), p < 0.0001.
Sources
- Original post
- FDA grants accelerated approval to iberdomide with daratumumab and hya - Linked page
- clin.larvol.com - Linked in the post
camizestrant accelerated approval with CDK4/6 inhibitor 16-month PFS
camizestrant (Etcamah) received FDA accelerated approval with a CDK4/6 inhibitor for HR-positive, HER2-negative breast cancer with ESR1 mutation, showing median PFS of 16 months versus 9.2 months. The Guardant360 CDx assay was approved as the companion diagnostic.
Key points
FDA granted accelerated approval on September 4 2026 for camizestrant plus a CDK4/6 inhibitor in ESR1-mutated HR-positive, HER2-negative breast cancer.
Median progression-free survival was 16 months (95% CI 12.7-18.2) with camizestrant + CDK4/6 inhibitor versus 9.2 months (95% CI 7.2-9.5) with AI + CDK4/6 inhibitor (HR 0.44, p < 0.00001).
Sources
- Original post
- FDA grants accelerated approval to camizestrant - Linked page
- clin.larvol.com - Linked in the post
nogapendekin alfa inbakicept-pmln FDA expanded indication
FDA approved nogapendekin alfa inbakicept-pmln with BCG for BCG-unresponsive non-muscle invasive bladder cancer including high-grade papillary-only tumors. The indication expands from prior approval that covered CIS with or without papillary disease. The approval is based on data from Cohort A of QUILT-3.032 (NCT03022825).
Key points
Approval date: October 14 2026.
Complete response rate in trial: 62% (95% CI 51-73).
Recommended induction dose: 400 µg intravesical weekly for 6 weeks with BCG.
Maintenance schedule: 400 µg weekly for 3 weeks at months 4, 7, 10, 13, 19, 25, 31, 37 (up to 37 months).
Sources
- Original post
- FDA approves an expanded indication for nogapendekin alfa inbakicept-p - Linked page
- clin.larvol.com - Linked in the post
Dostarlimab accelerated approval for MSI-H/dMMR stage II/III LARC
FDA granted accelerated approval to dostarlimab (Jemperli) for adults with stage II/III MSI-H/dMMR locally advanced rectal cancer. Approval follows trial data showing high clinical complete response and objective response rates.
Key points
FDA accelerated approval issued on October 19 2026.
AZUR-1 (NCT05723562) reported sustained cCR12 of 47% (95% CI 27-56%) and ORR of 79% (95% CI 71-85%) by independent central review.
Sources
- Original post
- FDA grants accelerated approval to dostarlimab for locally advanced re - Linked page
- clin.larvol.com - Linked in the post
- clin.larvol.com - Linked in the post
Minos app public beta launch, download now available
Minos app is now in public beta and can be downloaded from the website. Early testers helped find bugs and improve the app.
Key points
Public beta availability announced.
Download link provided on the website.
