Combination of Enasidenib & Azacitidine Significantly Improves Overall Response Rate in AML

 

A new study published in The Lancet Oncology suggests that the combination of enasidenib (Idhifa) and azacitidine are well tolerated and offer improved overall response rate (ORR) in recipients with newly-diagnosed IDH2-mutant acute myeloid leukemia (AML) compared with azacitidine monotherapy.

Enasidenib is specifically a small molecule, oral inhibitor of isocitrate dehydrogenase 2 (IDH2) inhibitor. The current standard of care in acute myeloid leukemia is induction together with myeloablative intensive chemotherapy.

For all those recipients who are not chemo eligible, either due to age or due to poor performance status, lower-intensity strategies are used. These include low doses of chemo and the consideration of targeted agents with FLT3 or IDH2 mutations.

The phase 1/2 findings compared azacitidine monotherapy to the experimental addition of azacitidine and enasidenib. The primary end points are dose-limiting toxicities, AEs, ORR, and pharmacokinetics. Secondary end points basically include event-free survival, complete remission, hematologic improvement rate, OS, duration of response, one-year survival, and time to response.

Phase-1 b assessed the efficacy, along with tolerability, and also clinical activity of the addition. During phase-2, the addition was compared head to head with azacitidine monotherapy.

In terms of safety, 91 percent of patients in the addition group and 81 percent of patients in the monotherapy group experienced adverse events. The common adverse events included thrombocytopenia, vomiting, neutropenia, anemia, and nausea.

Oxaliplatin: Antineoplastic medicine

Oxaliplatin is the medicine sold under the trade name Eloxatin. Oxaliplatin is an antineoplastic drug, which helps treat patients with stage III colon cancer and advanced colorectal cancer. It helps in the treatment of patients suffering from stage III colon cancer and advanced colorectal cancer. It comes in the form of lyophilized powder for solution in injection.

The active ingredient is Oxaliplatin and Lactose monohydrate is the inactive ingredient present in the medicine. The standard strengths of the medicine are 50 mg and 100 mg. According to the professionals, the general dosage of Oxaliplatin 100 mg is to give in combination with the other drug 5-fluorouracil/leucovorin every two weeks. This medicine has numerous side effects: allergic reaction, fatigue, abdominal pain, skin disorder, reaction at the injection site, nausea, diarrhea, vomiting, stomach-related problems, fever, infection, etc. 

One should only administer Oxaliplatin 100 mg injection according to the prescription of the healthcare professionals. Not every patient experiences these side effects of the medicine; if in case of side effects or an overdose of medication, consult the doctor for worsening of signs and symptoms. 

In India, there are numerous certified suppliers of such rare medicines that offer medicines at a lower price than innovators'. Ikris Pharma Network is one such trusted and certified supplier, and Oxaliplatin price is readily available at a reasonable price here. Ikris supplies medicines and medical aids in India and overseas.  

All about comparator drug

Comparator drugs are also known as reference-listed drugs. These drugs have already been approved and have a license. Also, these drugs are already being used in the market to treat patients. Comparing new generic versions with reference-listed drugs shows the biochemical similarity, having the same active ingredient and effect on patients. In its regulatory submissions, a drug company seeks approval to market a generic equivalent and refers to the Reference Listed Drug. 

There is heavy demand for alternatives to generic medicines in the pharmaceutical industry. Heavy demand for alternative generic medicines results in pressure on pharmaceutical companies to frame robust strategies for selecting a Comparator drug and then sourcing and maintaining an uninterrupted supply of that drug to all trial sites in a cost-effective manner. 

The top 10 pharmaceutical companies together spend more than $20 million every year on comparator sourcing. Innovators or drug producers, wholesalers, and local distributors can carry out direct comparator sourcing. 

Participation of Ikris in pharma industry as comparator drug sourcing

Ikris Pharma Network is an internationally acclaimed pharmaceutical wholesaler and service company. It has specialization in sourcing Comparator drug(s)/ innovator samples from worldwide (countries like India, USA, Europe, Canada, Australia, New Zealand, Korea, Japan, and Latin America). Ikris specifically is a one-stop source for all your requirements of innovator samples (single batch/multiple batches of specific quantities) for clinical trials as well as bioequivalence studies.

We have an internationally established supplying network that helps us procure, store, and provide the products from all the major pharmaceutical manufacturers and authorized distribution channels to and from any locations in the world, specific product sets in a bit huge volumes. We only work with approved sources and validated supply chains.

We have expertise in cold chain shipping and international customs requirements, which helps us ensure that the temperature-sensitive study drugs arrive within the required temperature range at the clinical trial facilities. We use reliable transportation that caters to cold, ambient, and everyday storage and delivery requirements. 

We provide regular updates and advise of product shortages or manufacturer delays allowing you to stay one step ahead and plan your study accordingly. 

We work with the best logistics and courier partners, which enable us to efficiently get your Comparator drug supply to you on or ahead of time.

Our Comparator drug sourcing service included:

• Clinical Trial Services 
• Investigational Medical Products and Comparators
• Rescue medication
• Co-medication
• Analytical samples