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 CT Designation 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 therapy Approval 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 NSCLC The 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 CT Approval 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-7375 The 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’25 Upon reaching the…

ByPrince GiriJune 25, 2025

NEWS

Dizal Reports Enrollment Completion in P-III (WU-KONG28) Trial of Sunvozertinib for EGFRm NSCLC

Shots: Dizal has completed pts enrollment in P-III (WU-KONG28) trial of sunvozertinib as a 1L treatment of NSCLC harboring EGFR exon 20 insertion mutations (exon20ins); NDA under the US FDA’s priority review (PDUFA: Jul 7, 2025) Trial assessed sunvozertinib vs Pt-based doublet CTs in treatment-naïve NSCLC pts with EGFR exon20ins across 16 countries & regions…

ByRidhi RastogiJune 20, 2025

NEWS

Nuvation Bio Reports the US FDA’s Approval of Ibtrozi to Treat Advanced ROS1+ NSCLC

Shots: The US FDA has approved Ibtrozi (taletrectinib) for treating locally advanced or metastatic ROS1+ NSCLC Approval was based on the P-II [TRUST-I (China) & TRUST-II (global)] studies assessing Ibtrozi monotx. in 173 & 164 pts with ROS1+ NSCLC, respectively TRUST-I showed a cORR of 90% in TKI-naïve pts, with longest DoR of 46.9mos. &…

ByRidhi RastogiJune 12, 2025

INSIGHTS+

The US FDA New Drug Approvals in May 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of May 2025 The US FDA has approved a total of 3 new drugs, including 2 new molecular entities and 1 Biologic leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was AbbVie’s Emrelis securing…

ByDipanshu DixitJune 10, 2025

NEWS

BMS Enters a ~$11.1B Deal with BioNTech to Jointly Develop and Commercialize BNT327

Shots: BMS & BioNTech will co-develop & co-commercialize BioNTech’s BNT327 alone & in combination to treat solid tumors; BMS to hold MA globally excl. the US, UK, China, Turkey, & EU, where BioNTech will be the holder As per the deal, BioNTech will receive $1.5B upfront, $2B in non-contingent annual payments through 2028 & ~$7.6B…

ByRidhi RastogiJune 3, 2025

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

Dizal Reports Enrollment Completion in P-III (WU-KONG28) Trial of Sunvozertinib for EGFRm NSCLC

Nuvation Bio Reports the US FDA’s Approval of Ibtrozi to Treat Advanced ROS1+ NSCLC

The US FDA New Drug Approvals in May 2025

BMS Enters a ~$11.1B Deal with BioNTech to Jointly Develop and Commercialize BNT327

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