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

NEWS

BMS’ Opdivo Receives the EC’s Approval as a Perioperative Treatment of Resectable NSCLC

Shots: The EC has approved Opdivo + CT as neoadj. therapy followed by surgery & adj. Opdivo alone to treat adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1% in all 30 EEA states Approval was based on P-III (CheckMate-77T) study assessing neoadj. Opdivo + CT vs neoadj. PBO & CT…

ByRidhi RastogiMay 19, 2025

NEWS

AbbVie’s Emrelis Receives the US FDA’s Accelerated Approval for NSCLC With High c-Met Protein Overexpression

Shots: The US FDA has granted accelerated approval to Emrelis (telisotuzumab vedotin-tllv) for treatment-experienced pts with locally advanced or metastatic, c-Met overexpressing, non-squamous NSCLC Approval was backed by an ongoing P-II (LUMINOSITY) study assessing Emrelis as 2L/3L treatment of c-Met overexpressing NSCLC; showing an ORR of 35% & mDoR of 7.2mos. in pts (n=84) with…

ByRidhi RastogiMay 16, 2025

NEWS

Johnson & Johnson Receives the EC’s Approval for SC Rybrevant to Treat Advanced EGFR-Mutated NSCLC

Shots: The EC has approved label extension to SC Rybrevant (Q1W x 4wks, then Q2W) + Lazcluze for 1L advanced NSCLC harboring EGFRm exon 19 del/ exon 21 L858R substitution & as monotx. for NSCLC pts with EGFRm exon 20 insertions unresponsive to Pt-based CT Approval was backed by P-III (PALOMA-3) trial, evaluating non-inferiority of…

ByRidhi RastogiApril 9, 2025

NEWS

AstraZeneca Reports the EC’s Approval of Imfinzi Regimen as Perioperative Treatment of NSCLC

Shots: The EC has approved perioperative Imfinzi regimen to treat resectable NSCLC adults at high risk of recurrence & no EGFR mutations or ALK rearrangements; MAA under PMDA review Approval was based on P-III (AEGEAN) trial assessing neoadj. Imfinzi (1500mg; Q3W × 4 cycles) + CT followed by adj. Imfinzi alone (Q4W × ~12 cycles)…

ByRidhi RastogiApril 4, 2025

NEWS

Johnson & Johnson Reports P-III (MARIPOSA) Trial Data of Rybrevant + Lazcluze for EGFRm NSCLC

Shots: J&J reported P-III (MARIPOSA) trial data assessing Rybrevant + Lazcluze vs osimertinib or Lazcluze alone as a 1L treatment of locally advanced or metastatic NSCLC pts (n=1074) with EGFR ex19del or L858R substitution mutations At 37.8mos. mFU, trial showed superior OS, with mOS not reached vs 36.7mos. for osimertinib-treated pts, plus 56% vs 44%…

ByRidhi RastogiApril 2, 2025

NEWS

BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC

Shots: The CHMP has recommended Opdivo + Pt-based CT as neoadj. followed by Opdivo alone as adj. treatment of adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1%. If approved, EC’s decision would be valid in all 30 EEA states The P-III (CheckMate-77T) study assessed neoadj. Opdivo + CT, followed by surgery…

ByRidhi RastogiMarch 31, 2025

NEWS

NANOBIOTIX and Janssen Amend Partnership to Develop and Commercialize JNJ-1900 (NBTXR3)

Shots: NANOBIOTIX & Janssen have amended their 2023 collaboration to develop & commercialize JNJ-1900 (NBTXR3), adjusting the deal value from $2.7B to $2.6B As per the revision, NANOBIOTIX will receive ~$1.77B in milestones related to cisplatin-ineligible HNSCC & inoperable stage 3 NSCLC, with ~$165M in milestones for China, South Korea, Singapore, & Thailand. J&J will cover…

ByRidhi RastogiMarch 18, 2025

NEWS

The US FDA Accepts NDA of Boehringer Ingelheim’s Zongertinib for HER2 (ERBB2)-Mutant NSCLC

Shots: The US FDA has accepted & granted priority review to the NDA of zongertinib (BI 1810631) for the treatment of pts with inoperable or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapy (PDUFA: Q3’25) Submission was based on P-Ib (Beamion LUNG-1) trial assessing zongertinib as Monotx. in 2 arms…

ByRidhi RastogiFebruary 20, 2025

NEWS

BMS Reports P-III (CheckMate-816) Trial Data of Opdivo as a Neoadjuvant Treatment of Resectable NSCLC

Shots: BMS has reported final data from P-III (CheckMate-816) trial of neoadj. Opdivo + Pt-doublet CT to treat adults with operable NSCLC (tumors ≥4cm or node positive) The P-III (CheckMate-816) trial evaluates Opdivo (360mg, Q3W for 3 cycles) + CT vs CT alone in 358 pts with resectable stage IB to IIIA NSCLC regardless…

ByRidhi RastogiFebruary 19, 2025

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

BMS’ Opdivo Receives the EC’s Approval as a Perioperative Treatment of Resectable NSCLC

AbbVie’s Emrelis Receives the US FDA’s Accelerated Approval for NSCLC With High c-Met Protein Overexpression

Johnson & Johnson Receives the EC’s Approval for SC Rybrevant to Treat Advanced EGFR-Mutated NSCLC

AstraZeneca Reports the EC’s Approval of Imfinzi Regimen as Perioperative Treatment of NSCLC

Johnson & Johnson Reports P-III (MARIPOSA) Trial Data of Rybrevant + Lazcluze for EGFRm NSCLC

BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC

NANOBIOTIX and Janssen Amend Partnership to Develop and Commercialize JNJ-1900 (NBTXR3)

The US FDA Accepts NDA of Boehringer Ingelheim’s Zongertinib for HER2 (ERBB2)-Mutant NSCLC

BMS Reports P-III (CheckMate-816) Trial Data of Opdivo as a Neoadjuvant Treatment of Resectable NSCLC

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