Opdivo

BMS Reports Five-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -214 for the Treatment of Advanced or Metastatic Renal Cell Carcinoma

Shots: The P-III CheckMate -214 trial evaluates Opdivo (3mg/kg) + Yervoy (1mg/kg, q3w for 4 doses) vs sunitinib in 1096 patients with previously untreated advanced/mRCC Results: @median follow-up of 67.7mos., combination showed superior OS in intermediate, poor risk patients & randomized or ITT population; m-OS (47.0 vs 26.6mos.) & (55.7 vs 38.4mos.); ORR (42% vs …

BMS Reports Five-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -214 for the Treatment of Advanced or Metastatic Renal Cell Carcinoma Read More »

ONO and BMS Report Submission of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L Treatment of Unresectable Advanced or Recurrent ESCC in Japan

Shots: The application is based on P-III CheckMate -648 study evaluating Opdivo (3mg/kg, q2w, IV) + Yervoy (1mg/kg, q6w up to 24mos.) or Opdivo + CT vs CT alone in patients with unresectable advanced or recurrent ESCC The results demonstrated an improvement in OS at pre-specified interim analysis in patients with tumor cell PD-L1 expression …

ONO and BMS Report Submission of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L Treatment of Unresectable Advanced or Recurrent ESCC in Japan Read More »

BMS Reports Three-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -743 Trial for 1L Treatment of Unresectable Malignant Pleural Mesothelioma

Shots: The P-III CheckMate -743 trial evaluates Opdivo (3mg/kg, q2w) + Yervoy (1mg/kg, q6w) vs CT in 605 patients with previously untreated unresectable MPM. The results will be presented at ESMO 2021 The result showed an improvement in OS with a reduction in risk of death, patients were alive (23% vs 15%) @3yrs., improvement in …

BMS Reports Three-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -743 Trial for 1L Treatment of Unresectable Malignant Pleural Mesothelioma Read More »

BMS gets FDA nod for Opdivo as first adjuvant bladder cancer therapy

Bristol-Myers Squibb has scored a win in its drive to get Opdivo into earlier lines of cancer therapy, getting FDA approval for the drug for post-surgical treatment of invasive bladder cancer. The new adjuvant use for Opdivo (nivolumab) is for patients with urothelial carcinoma (UC) – the most common form of bladder cancer – who …

BMS gets FDA nod for Opdivo as first adjuvant bladder cancer therapy Read More »

GSK claims broader ’tissue-agnostic’ label for PD-1 drug Jemperli

The FDA has approved GlaxoSmithKline’s latecomer PD-1 inhibitor Jemperli for a second use that will significantly extend the patient population eligible for treatment with the drug. Jemperli (dostarlimab) can now be used to treat adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours – regardless of where they are located in the body – …

GSK claims broader ’tissue-agnostic’ label for PD-1 drug Jemperli Read More »

BMS Reports EMA’s Validation of MAA for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + CT to Treat Esophageal Squamous Cell Carcinoma

Shots: The applications are based on P-III CheckMate -648 trial evaluates Opdivo (3 mg/kg, q2w) + Yervoy (1 mg/kg, q6w up to 24mos.) or Opdivo (nivolumab) + CT vs CT alone in patients with unresectable advanced or metastatic ESCC Results: Both combinations showed OS benefit over CT at the pre-specified interim analysis in patients with …

BMS Reports EMA’s Validation of MAA for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + CT to Treat Esophageal Squamous Cell Carcinoma Read More »

BMS claims first EU okay for adjuvant oesophageal cancer immunotherapy

Bristol-Myers Squibb is in a battle with Merck & Co for position in the upper gastrointestinal cancer immunotherapy market, and has just reinforced its position with an EU approval in the post-surgery (adjuvant) setting. The European Commission has approved Opdivo (nivolumab) as the first-ever adjuvant immunotherapy for patients with oesophageal or gastroesophageal junction (GEJ) cancer, …

BMS claims first EU okay for adjuvant oesophageal cancer immunotherapy Read More »

BridgeBio Enters into Clinical Collaboration with BMS to Evaluate BBP-398 + Opdivo for Advanced Solid Tumors with KRAS Mutations

Shots: The companies will initiate P-I/II study evaluating the safety and preliminary efficacy of BBP-398 in combination with both Opdivo as dual therapy & Opdivo + KRASG12C inhibitor as triplet therapy in NSCLC patients with KRAS mutations, as 1L & 2L treatment options BridgeBio will sponsor the study while BMS will provide nivolumab to the …

BridgeBio Enters into Clinical Collaboration with BMS to Evaluate BBP-398 + Opdivo for Advanced Solid Tumors with KRAS Mutations Read More »

Bristol Myers pulls Opdivo for use in liver cancer amid broader FDA scrutiny of speedy approvals

Bristol Myers Squibb blockbuster drug Opdivo is being pulled from the market after failing to meet the main goal of a confirmatory study. The voluntary withdrawal comes amid broader FDA scrutiny of cancer drugs that were given accelerated approval.

BMS pulls speedy Opdivo approval for liver cancer in US

Bristol-Myers Squibb has withdrawn its US marketing approval for PD-1 inhibitor Opdivo as a second-line, single-agent treatment for hepatocellular carcinoma, a common form of liver cancer, in people previously treated with Bayer/Onyx’s Nexavar. Opdivo (nivolumab) was awarded an accelerated approval in 2017 for second-line HCC treatment on the strength of mid-stage data, but failed to …

BMS pulls speedy Opdivo approval for liver cancer in US Read More »

BMS Presents Results of Opdivo (nivolumab) + CT or Yervoy (ipilimumab) in P-III CheckMate -648 Trial for Unresectable Advanced or Metastatic ESCC at ASCO 2021

Shots: The P-III CheckMate -648 trial evaluating Opdivo + CT or Opdivo (3 mg/kg, q2w) + Yervoy (1 mg/kg, q6w up to 24mos.) in patients with unresectable advanced or metastatic ESCC Results: Both combinations showed OS benefits over CT in PD-L1 positive & all-randomized populations, m-OS for Opdivo + CT (13.7 vs 9.1 mos. & …

BMS Presents Results of Opdivo (nivolumab) + CT or Yervoy (ipilimumab) in P-III CheckMate -648 Trial for Unresectable Advanced or Metastatic ESCC at ASCO 2021 Read More »

ONO and BMS’ Opdivo + Yervoy Receive Approval for 1L Treatment for Unresectable Advanced or Recurrent Malignant Pleural Mesothelioma

Shots: The approval is based on P-III CheckMate -743 study assessing Opdivo + Yervoy vs SOC Pt. based CT in patients with previously untreated unresectable malignant pleural mesothelioma The combination regimen has demonstrated significant extension of OS vs CT. The safety profile of combination treatment was consistent with those previously reported in the studies for …

ONO and BMS’ Opdivo + Yervoy Receive Approval for 1L Treatment for Unresectable Advanced or Recurrent Malignant Pleural Mesothelioma Read More »

BMS Receive the CHMP’s Positive Opinion Recommending Approval of Opdivo (nivolumab) + Yervoy (ipilimumab) for dMMR or MSI-H mCRC After Prior Chemotherapy

Shots: The opinion is based on P-II CheckMate -142 study assessing Opdivo + Yervoy in patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer whose disease had progressed during or after prior treatment with CT If approved, Opdivo in combination with Yervoy will be the first dual immunotherapy approved in the EU in …

BMS Receive the CHMP’s Positive Opinion Recommending Approval of Opdivo (nivolumab) + Yervoy (ipilimumab) for dMMR or MSI-H mCRC After Prior Chemotherapy Read More »

BMS Reports the US FDA’s Acceptance of Opdivo’s sBLA for Priority Review to Treat Muscle Invasive Urothelial Carcinoma

Shots: The filing is based on results from the P-III CheckMate -274 trial evaluating Opdivo (240mg, q2w for up to 1 yrs.) vs PBO in a ratio (1:1) in 709 patients with muscle-invasive urothelial cancer who are at a high risk of recurrence after radical surgery The study demonstrated the improvement in DFS regardless of …

BMS Reports the US FDA’s Acceptance of Opdivo’s sBLA for Priority Review to Treat Muscle Invasive Urothelial Carcinoma Read More »

Keytruda should lose stomach cancer indication, says ODAC

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted to strip Merck & Co’s Keytruda of its accelerated approval in gastric and gastroesophageal junction (GEJ) cancer, despite a lack of treatment options in these patients.  The panel voted 6 to 2 that Keytruda (pembrolizumab) should not stay on the market for PD-L1–positive gastric or GEJ …

Keytruda should lose stomach cancer indication, says ODAC Read More »

BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML

Shots: The CHMP has recommended the approval of Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L treatment for unresectable MPM and is based P-III CheckMate -743 trial that met its 1EPs of OS The opinion for Onureg is based P-III QUAZAR AML-001 study assessing Onureg (300mg, qd) vs PBO in 472 patients in a ratio (1:1) …

BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML Read More »

BMS’ Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive CHMP’s Positive Opinion as 1L Treatment for Advanced Renal Cell Carcinoma

Shots: The CHMP recommendation is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC The P-III result showed improvements in PFS, OS and ORR with consistent efficacy benefits observed across key subgroups of patients and was well tolerated, with a low …

BMS’ Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive CHMP’s Positive Opinion as 1L Treatment for Advanced Renal Cell Carcinoma Read More »

Merck gets a leg-up for Keytruda in first-line kidney cancer

New phase 3 data have shored up the position of Merck & Co’s cancer immunotherapy Keytruda in the increasingly competitive first-line kidney cancer market.  The data from the KEYNOTE-581/CLEAR study reveal that the combination of PD-1 inhibitor Keytruda (pembrolizumab) with Eisai’s targeted tyrosine kinase inhibitor Lenvima (lenvatinib) reduced the risk of disease progression of death …

Merck gets a leg-up for Keytruda in first-line kidney cancer Read More »

Heat Bio’s shares ignite on Opdivo combination data in NSCLC

The pairing of Heat Biologics’ lead drug HS-110 with Bristol-Myers Squibb’s blockbuster checkpoint inhibitor Opdivo has boosted survival in patients with non-small cell lung cancer (NSCLC), sending the biotech’s share price skywards.  Interim data from a phase 2 trial of Heat’s off-the-shelf cell therapy with Opdivo (nivolumab) showed that patients treated with the duo as …

Heat Bio’s shares ignite on Opdivo combination data in NSCLC Read More »

Unconvinced by NHS test run, NICE rejects BMS’ Opdivo in head and neck cancer

NICE has rejected Bristol Myers Squibb’s immunotherapy Opdivo as a second-line treatment for head and neck cancer in first draft guidance, unconvinced by evidence unearthed during a three-year NHS trial period. In its latest guidance, NICE said that clinical trial data gathered so far and real-world evidence did not convince about the cost-effectiveness of Opdivo …

Unconvinced by NHS test run, NICE rejects BMS’ Opdivo in head and neck cancer Read More »

BMS calls time on brain cancer trial as Opdivo misses second target

Bristol Myers-Squibb has put out another downbeat “update” announcement about its immunotherapy Opdivo in an aggressive form of brain cancer, saying that it looks unlikely to produce a survival benefit in the disease. BMS said an independent committee had reviewed data from the phase 3 CheckMate-548 trial in newly diagnosed MGMT-methylated glioblastoma multiforme and concluded …

BMS calls time on brain cancer trial as Opdivo misses second target Read More »

BMS’ Opdivo (nivolumab) Receives EC’s Approval as 2L Treatment for Unresectable Advanced and Metastatic Esophageal Squamous Cell Carcinoma

Shots: The approval is based on P-lll ATTRACTION-3 study involve the assessment of Opdivo vs CT (docetaxel or paclitaxel) for patients with esophageal cancer refractory/ intolerant to 1L combination therapy with fluoropyrimidine- and Pt.-based drugs Results: reduction in risk of death (23%); m-OS (10.9 vs 8.4 mos.); @12 & 18-mos. OS rates (47% & 31% …

BMS’ Opdivo (nivolumab) Receives EC’s Approval as 2L Treatment for Unresectable Advanced and Metastatic Esophageal Squamous Cell Carcinoma Read More »

FDA kicks off review of second kidney cancer combo based on BMS’ Opdivo

Bristol-Myers Squibb could be mere months away from claiming a second US approval for an Opdivo-based combination immunotherapy that will help defend its first-line kidney cancer franchise. The FDA has started a priority review of PD-1 inhibitor Opdivo (nivolumab) alongside Exelixis’ tyrosine kinase inhibitor Cabometyx (cabozantinib) in previously-untreated advanced renal cell carcinoma (RCC) – the …

FDA kicks off review of second kidney cancer combo based on BMS’ Opdivo Read More »

BMS Report Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable Non-Small Cell Lung Cancer

Shots: The P-III CheckMate-816 study involves assessing of Opdivo (360mg) + CT (q3w for 3 doses) vs CT (q3w for 3 doses), followed by surgery as a neoadjuvant treatment in 358 patients with resectable NSCLC The study met its 1EPs of improved pathologic complete response. The positive results marks the first time an immune checkpoint …

BMS Report Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable Non-Small Cell Lung Cancer Read More »

FDA approves BMS’ Opdivo and Yervoy combination in first-line mesothelioma

Bristol-Myers Squibb’s immunotherapy combination of Opdivo and Yervoy has been approved in the US in a new indication for untreated mesothelioma, a rare but aggressive form of cancer that forms in the lining of the lungs. The FDA has approved Opdivo (nivolumab) and Yervoy (ipilimumab), as the first and only immunotherapy for previously untreated unresectable …

FDA approves BMS’ Opdivo and Yervoy combination in first-line mesothelioma Read More »

BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer

Shots: The approval is based on P-III CheckMate -9LA study assessing Opdivo + Yervoy combined with two cycles of platinum-doublet CT vs CT (four cycles followed by optional pemetrexed maintenance therapy if eligible) as a 1L treatment in patients with metastatic/ recurrent NSCLC regardless of PD-L1 expression and histology The study met its 1EPs & …

BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer Read More »

BMS’ Opdivo aces trial in asbestos-linked lung cancer

Bristol-Myers Squibb’s Opdivo has improved survival in a trial involving patients with mesothelioma, a form of lung cancer, getting one up over rival checkpoint inhibitor Keytruda from Merck & Co. The results of the CheckMate-743 trial showed that a combination of Opdivo (nivolumab) with low-dose Yervoy (ipilimumab) reduced the risk of death by 26% compared …

BMS’ Opdivo aces trial in asbestos-linked lung cancer Read More »

Roche’s Tecentriq claims melanoma OK, but don’t expect a sales surge

Roche’s checkpoint inhibitor Tecentriq has been cleared for another new use in the US – in melanoma – but could struggle to displace rival drugs from Bristol-Myers Squibb and Merck & Co. The FDA has approved the PD-L1 inhibitor as a combination with two targeted drugs – MEK inhibitor Cotellic (cobimetinib) and BRAF inhibitor Zelboraf …

Roche’s Tecentriq claims melanoma OK, but don’t expect a sales surge Read More »

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The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they …

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