Merck Reports P-III (KEYNOTE C93) Trial Data on Keytruda for Endometrial Cancer with dMMR Tumors

Shots: Merck has reported the P-III (KEYNOTE‑C93) trial assessing Keytruda (400mg, IV, Q6W for ~18 cycles) vs carboplatin + paclitaxel in pts (n=299) with dMMR advanced or recurrent endometrial cancer who have not previously been treated with systemic CT Trial met its 1EP of improved PFS, & showed improvements across ORR, CRR, & DoR; OS (1EP)…

ByRidhi RastogiJuly 15, 2026

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Roche Receives the US FDA Priority Review for Gazyva to Treat Primary Membranous Nephropathy

Shots: The US FDA has granted Priority Review to the sBLA of Gazyva/Gazyvaro (obinutuzumab) in pMN, based on the P-III (MAJESTY) study assessing Gazyva vs tacrolimus in adults (n=142), with a decision expected by Nov 2026 Trial met its 1EP, with 36.9% adults achieving CR at 2yrs. vs 5.7%, plus showed superiority across key 2EPs…

ByRidhi RastogiJuly 15, 2026

NEWS

Kelun-Biotech Reports P-III Trial Findings on sac-TMT + Keytruda for 1L PD-L1-Negative Non-Squamous NSCLC

Shots: Kelun-Biotech has reported P-III (OptiTROP-Lung06) trial data assessing sacituzumab tirumotecan (sac-TMT/SKB264/MK-2870) + Keytruda vs CT + Keytruda as the 1L treatment for PD-L1-negative locally advanced or metastatic non-squamous NSCLC (TPS <1%) IDMC has concluded that the trial met its 1EP of improved PFS at interim analysis vs Keytruda + pemetrexed & Pt-based CT, plus…

ByRidhi RastogiJuly 15, 2026

NEWS

The US FDA Approves Celcuity’s Revtorpyk (Gedatolisib) to Treat HR+/HER2- PIK3CA Wild-Type Breast Cancer

Shots: FDA has approved Revtorpyk for HR+, HER2-, PIK3CA wild-type locally advanced or metastatic breast cancer that has progressed after ≥1L of endocrine therapy (ET) in the metastatic setting; launch expected in late Q3’26 Approval was backed by PIK3CA wild-type cohort data from P-III (VIKTORIA-1), where Revtorpyk + fulvestrant + palbociclib improved mPFS (9.3 vs…

ByRidhi RastogiJuly 15, 2026

NEWS

BMS Reports US FDA’s NDA Acceptance of Mezigdomide Combination to Treat R/R Multiple Myeloma

Shots: The US FDA has accepted NDA of mezigdomide (PO) + carfilzomib & dexamethasone (MeziKd) for the treatment of pts with r/r multiple myeloma (PDUFA: May 13, 2027) NDA was supported by the P-III (SUCCESSOR-2) trial data assessing MeziKd in 2 stages, where in stage 2, 479 pts with r/r MM were randomized to either MeziKd…

ByRidhi RastogiJuly 13, 2026

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The US FDA Approves Sanofi’s Sarclisa Escena to Treat Multiple Myeloma (MM)

Shots: The US has approved Sarclisa Escena (isatuximab-irfc; SC) + SoC for the treatment of pts with MM across all existing indications of Sarclisa IV formulation Approval was backed by multiple trials, incl. P-III (IRAKLIA) in R/R MM, which showed shorter treatment time & fewer infusion-related reactions with Sarclisa Escena In IRAKLIA, SC Sarclisa delivered…

ByRidhi RastogiJuly 13, 2026

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Merck, Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Cisplatin-Eligible MIBC Patients

Shots: The US FDA has approved Padcev (enfortumab vedotin) + Keytruda/Keytruda Qlex for neoadj. & adj. treatment for pts with muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility Approval was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs neoadj. SoC + surgery in cisplatin-eligible MIBC…

ByRidhi RastogiJuly 13, 2026

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Hansoh Reports P-III (ARTEMIS-008) Trial Data on Risvutatug Rezetecan for Advanced or Relapsed SCLC

Shots: Hansoh has reported the P-III (ARTEMIS-008) trial results assessing risvutatug rezetecan (Ris-Rez/HS-20093) vs topotecan in pts with advanced or relapsed SCLC after prior Pt-based therapy Trial met its 1EP of improved OS in the interim analysis, with consistent benefit also observed across 2EPs, incl. PFS; data will be presented at an upcoming conference Based on…

ByRidhi RastogiJuly 10, 2026

NEWS

Ipsen Reports Topline P-III (BEOND) Trial Program Data on Dysport in Both Episodic and Chronic Migraine

Shots: Ipsen has reported topline P-III (E-BEOND & C-BEOND) trial results assessing Dysport (abobotulinumtoxinA) vs PBO in a total of 1,510 adults with episodic & chronic migraine, respectively Both trials met their 1EP, with a reduction in monthly migraine days vs PBO & demonstrated a favorable safety profile; detailed results will be presented at a future…

ByRidhi RastogiJuly 9, 2026

NEWS

Immunome Reports the US FDA’s NDA Acceptance of Varegacestat to Treat Desmoid Tumors in Adults

Shots: The US FDA has accepted the NDA for Immunome’s varegacestat for the treatment of adults with desmoid tumors, with a PDUFA target action date of Apr 28, 2027 NDA is supported by the global P-III (RINGSIDE) trial assessing varegacestat (1.2mg, QD) vs PBO until disease progression or death in 156 pts with progressing desmoid…

ByRidhi RastogiJuly 8, 2026

Merck Reports P-III (KEYNOTE C93) Trial Data on Keytruda for Endometrial Cancer with dMMR Tumors

Roche Receives the US FDA Priority Review for Gazyva to Treat Primary Membranous Nephropathy

Kelun-Biotech Reports P-III Trial Findings on sac-TMT + Keytruda for 1L PD-L1-Negative Non-Squamous NSCLC

The US FDA Approves Celcuity’s Revtorpyk (Gedatolisib) to Treat HR+/HER2- PIK3CA Wild-Type Breast Cancer

BMS Reports US FDA’s NDA Acceptance of Mezigdomide Combination to Treat R/R Multiple Myeloma

The US FDA Approves Sanofi’s Sarclisa Escena to Treat Multiple Myeloma (MM)

Merck, Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Cisplatin-Eligible MIBC Patients

Hansoh Reports P-III (ARTEMIS-008) Trial Data on Risvutatug Rezetecan for Advanced or Relapsed SCLC

Ipsen Reports Topline P-III (BEOND) Trial Program Data on Dysport in Both Episodic and Chronic Migraine

Immunome Reports the US FDA’s NDA Acceptance of Varegacestat to Treat Desmoid Tumors in Adults

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