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Bristol-Myers Squibb Pharmaceuticals Limited has informed the MHRA that a potential product quality issue has been detected, relating to incomplete crimping of the metal crimp cap of OPDIVO 10mg/mL concentrate for solution for infusion (nivolumab) (1VLX10ML).
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (27 December) approved the advanced melanoma medicine Opdualag (nivolumab-relatlimab) for patients from the age of 12.
EAMS scientific opinion issued to Bristol-Myers Squibb Pharmaceuticals Limited for Nivolumab as monotherapy treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal, squamous cell carcinoma (OSCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
EAMS scientific opinion issued to Bristol-Myers Squibb Pharmaceuticals Limited for nivolumab to be used in combination with ipilimumab in the treatment of malignant pleural mesothelioma (a type of cancer that affects the lining of the lung) in adults.
Patients on nivolumab who present with diarrhoea or other symptoms of colitis, and those who do not respond to steroid treatment for immune-related colitis, should be investigated to exclude other causes, including infections such as cytomegalovirus (CMV).
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
There have been reports of rejection of solid organ transplants in patients treated with nivolumab or pembrolizumab. Ipilimumab (Yervoy▼) may also interfere with immunosuppressive therapy, increasing the risk of graft rejection.
Patients on ipilimumab who present with diarrhoea or other symptoms of colitis, and those who do not respond to steroid treatment for immune-related colitis, should be investigated to exclude other causes, including infections such as cytomegalovirus (CMV). There have been...
Cases of severe cutaneous adverse reactions, including Stevens-Johnsons syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients treated with immune-stimulatory anti-cancer drugs, including atezolizumab. Advise patients to be vigilant for the signs of severe skin reactions and...
For the first time, patients with certain types of advanced or recurrent endometrial cancer could access a treatment shown to slow its progression
Information and sources of further guidance relating to the current shortage of products used in the treatment of some bladder cancers
A retrospective cohort study in Armenia, India, and South Africa
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