The US FDA Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma (HCC)

Shots: The US FDA has approved Opdivo + Yervoy as 1L therapy to treat inoperable or advanced HCC adults Approval was based on P-III (CheckMate-9DW) trial assessing Opdivo (1mg/kg, Q3W) + Yervoy (3mg/kg, Q3W), followed by Opdivo alone (480mg, Q4W) vs lenvatinib/sorafenib in 668 pts with advanced HCC who had not received prior systemic therapy.…

ByRidhi RastogiApril 14, 2025

NEWS

BMS Reports the US FDA’s Approval of Opdivo + Yervoy as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)

Shots: The US FDA has approved Opdivo + Yervoy for 1L treatment of MSI-H/dMMR unresectable mCRC pts (≥12yrs.) based on P-III (CheckMate-8HW) study assessing Opdivo + Yervoy vs Opdivo alone or CT in 839 pts (Approved before PDUFA: Jun 23, 2025) Regimen vs Opdivo monotx. showed 38% PFS (mPFS: not reached (NR) vs 39.3mos) in…

ByRidhi RastogiApril 9, 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

The EC Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma

Shots: The EC has approved Opdivo + Yervoy as 1L therapy to treat inoperable or advanced HCC adult pts in 30 EEA states; sBLA under the US FDA’s priority review (PDUFA: Apr 21, 2025) Approval was based on P-III (CheckMate-9DW) trial assessing Opdivo (1mg/kg, Q3W) + Yervoy (3mg/kg, Q3W), followed by Opdivo alone (480mg,…

ByRidhi RastogiMarch 10, 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

INSIGHTS+

The US FDA New Drug Approvals in December 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of December 2024 The US FDA has approved a total of 10 new drugs including 4 new molecular entities and 6 biologics leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was BMS’ Opdivo Qvantig…

ByDipanshu DixitJanuary 14, 2025

NEWS

Xbrane Biopharma and Intas Pharmaceuticals Join Forces to Develop Biosimilar of Opdivo (Nivolumab)

Shots: Xbrane and Intas have entered into a global licensing and co-development agreement for Xbrane's biosimilar of Opdivo (nivolumab). Intas, through its Accord Healthcare, will commercialize the biosimilar, leveraging its oncology expertise and significant market presence in the EU As per the agreement, Intas will fund and manage clinical as well as regulatory development, and…

ByDipanshu DixitNovember 19, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in May 2024

Shots: The EMA approved or granted Positive Opinions to 5 Biologics and 7 New Chemical Entities in May 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were BMS’ Opdivo + cisplatin & gemcitabine to treat Urothelial Carcinoma and Takeda’s ADAMTS13 for the treatment cTTP PharmaShots has compiled…

ByDipanshu DixitJune 20, 2024

NEWS

BMS’ Opdivo Plus Cisplatin and Gemcitabine Gain EC’s Approval for Treating Urothelial Carcinoma

Shots: The EC has approved Opdivo + cisplatin & gemcitabine as 1L treatment of unresectable or metastatic urothelial carcinoma (UC) adults, valid across the whole EU along with Iceland, Liechtenstein & Norway, based on the P-III (CheckMate -901) study The P-III (CheckMate -901) study assessed Opdivo + Yervoy or Opdivo + cisplatin & gemcitabine…

ByDipanshu DixitMay 29, 2024

NEWS

BMS Receives the CHMP’s Positive Opinion for Opdivo (Nivolumab) as a 1L Treatment of Urothelial Carcinoma

Shots: The CHMP has granted positive opinion to Opdivo + CT (cisplatin & gemcitabine) as 1L treatment of metastatic or unresectable urothelial carcinoma adults (n=608). The decision is anticipated in Jun 2024 The opinion was based on a sub-study of the P-III (CheckMate–901), assessing Opdivo (360mg, Q3W, 6 cycles) + CT (cisplatin & gemcitabine) followed…

ByDipanshu DixitApril 26, 2024

The US FDA Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma (HCC)

BMS Reports the US FDA’s Approval of Opdivo + Yervoy as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)

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

The EC Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma

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

The US FDA New Drug Approvals in December 2024

Xbrane Biopharma and Intas Pharmaceuticals Join Forces to Develop Biosimilar of Opdivo (Nivolumab)

Insights+: EMA Marketing Authorization of New Drugs in May 2024

BMS’ Opdivo Plus Cisplatin and Gemcitabine Gain EC’s Approval for Treating Urothelial Carcinoma

BMS Receives the CHMP’s Positive Opinion for Opdivo (Nivolumab) as a 1L Treatment of Urothelial Carcinoma

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