The NMPA Grants Conditional Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

Shots:China’s NMPA has granted conditional approval to Hernexeos (zongertinib) for treating pts with inoperable, locally advanced or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapyApproval was based on P-Ib (Beamion LUNG-1) trial assessing Hernexeos alone, which showed improved ORR of 71% (N=75: 7% CR), mDoR of 14.1mos. & mPFS…

ByRidhi RastogiSeptember 1, 2025

NEWS

TOLREMO Therapeutics’ TT125-802 Secures 2 US FDA’s Fast-Track Designation for NSCLC with EGFR & KRAS-G12C Mutation

Shots:The US FDA has granted 2 FTDs to TT125-802 for NSCLC: one for EGFR exon 19 deletion or exon 21 L858R mutation pts progressing after EGFR inhibitors, & another for KRAS G12C-mutated pts progressing after KRAS G12C inhibitorsTT125-802 is being assessed in P-I trial to evaluate its safety, tolerability, PK, & efficacy in…

ByRidhi RastogiAugust 29, 2025

NEWS

BeOne Medicine’s Perioperative Tevimbra (Tislelizumab) Receives the EC’s Approval for Resectable NSCLC

Shots:The EC has approved neoadj. Tevimbra + Pt-based CT followed by adj. Tevimbra monotx. for adults with resectable NSCLC at high risk of recurrenceApproval was based on P-III (RATIONALE-315) trial assessing perioperative Tevimbra with CT before surgery vs PBO + CT in NSCLC pts (n=453), which met its dual 1EPs of EFS &…

ByRidhi RastogiAugust 27, 2025

NEWS

HUTCHMED Completes Patient Enrolment in P-III (SANOVO) Trial of Orpathys (savolitinib) and Tagrisso (osimertinib) for EGFRm NSCLC

Shots:HUTCHMED has completed enrolment in its P-III (SANOVO) trial to assess Orpathys + Tagrisso as a 1L treatment of pts with locally advanced or metastatic NSCLC harboring EGFR mutation & MET overexpression; last patient was enrolled in Aug 18, 2025Trial will evaluate Orpathys + Tagrisso vs Tagrisso in NSCLC pts, assessing PFS as 1EP,…

ByRidhi RastogiAugust 20, 2025

NEWS

SystImmune and BMS’ Izalontamab Brengitecan Secures the US FDA’s Breakthrough Therapy Designation to Treat EGFRm NSCLC

Shots:The US FDA has granted BTD to izalontamab brengitecan (iza-bren) for LA/M NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations progressing on or after EGFR TKI & Pt-based CTDesignation was backed by data from 3 ongoing trials: BL-B01D1-101 & BL-B01D1-203 in China led by Sichuan Biokin, & the global BL-B01D1-LUNG-101…

ByRidhi RastogiAugust 18, 2025

NEWS

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

Shots:The US FDA has granted accelerated approval to Hernexeos (zongertinib) for the treatment of pts with inoperable or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapyApproval was based on P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 75% (N=71: 6% CR & 69% PR)…

ByRidhi RastogiAugust 11, 2025

NEWS

AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC

Shots:AstraZeneca has reported P-III (FLAURA2) trial findings on Tagrisso + Pt-based CT as a 1L treatment of pts with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLCThe P-III (FLAURA2) trial assessed Tagrisso (80mg, QD, PO) + pemetrexed + cisplatin/carboplatin (Q3W for 4 cycles) followed by Tagrisso + pemetrexed maintenance (Q3W) vs…

ByRidhi RastogiJuly 21, 2025

INSIGHTS+

The US FDA New Drug Approvals in June 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of June 2025 The US FDA has approved a total of 5 new drugs, including 2 new molecular entities and 3 biologics, leading to the treatment of patients and advances in the pharmaceutical industry The major highlighted drug was Daiichi Sankyo and AstraZeneca’s Datroway, securing…

ByDipanshu DixitJuly 15, 2025

NEWS

Daiichi Sankyo and AstraZeneca Report the US FDA Approval of Datroway for Advanced EGFR-Mutated NSCLC

Shots:The US FDA has approved Datroway (datopotamab deruxtecan-dlnk; 6 mg/kg) for adults with locally advanced or metastatic EGFR-mutated NSCLC previously treated with EGFR therapy & Pt CTApproval was based on the global P-II (TROPION-Lung05) trial results (n=137) and supported by data from the P-III (TROPION-Lung01) trial (n=590), which showed a 45% confirmed ORR…

ByDipanshu DixitJune 26, 2025

NEWS

Verastem Oncology Reports First Patient Dosing with VS-7375 in P-I/IIa Study for KRAS G12D Advanced Solid Tumors

Shots:Verastem reported the dosing of the first patient (US) for P-I/IIa study (VS-7375-101) assessing the safety, tolerability, and efficacy of VS-7375The dose-escalation phase of the study starts at 400mg, based on results from a P-I/II study conducted by GenFleet in China, and presented initial safety and efficacy data at ASCO’25Upon reaching the…

ByPrince GiriJune 25, 2025

The NMPA Grants Conditional Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

TOLREMO Therapeutics’ TT125-802 Secures 2 US FDA’s Fast-Track Designation for NSCLC with EGFR & KRAS-G12C Mutation

BeOne Medicine’s Perioperative Tevimbra (Tislelizumab) Receives the EC’s Approval for Resectable NSCLC

HUTCHMED Completes Patient Enrolment in P-III (SANOVO) Trial of Orpathys (savolitinib) and Tagrisso (osimertinib) for EGFRm NSCLC

SystImmune and BMS’ Izalontamab Brengitecan Secures the US FDA’s Breakthrough Therapy Designation to Treat EGFRm NSCLC

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC

The US FDA New Drug Approvals in June 2025

Daiichi Sankyo and AstraZeneca Report the US FDA Approval of Datroway for Advanced EGFR-Mutated NSCLC

Verastem Oncology Reports First Patient Dosing with VS-7375 in P-I/IIa Study for KRAS G12D Advanced Solid Tumors

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