Archive for the ‘Chemotherapeutic / Anti-Neoplastic’ Category

Early EU Approval for Ibrutinib

Tuesday, October 21st, 2014

IbrutinibThe early EU approval for Ibrutinib was granted by the European Commission (EC), for Ibrutinib to be sold in the 28 European Union (EU) member states.

Ibrutinib is a first-in-class, oral, once-daily, non-chemotherapy treatment option, and will be used to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).

This likely new cancer blockbuster is marketed as the trade name Imbruvica, and is being jointly developed and commercialized in the U.S. by Pharmacyclics and Janssen Biotech, Inc. (Janssen). Janssen affiliates will sell Imbruvica in EMEA (Europe, Middle East, Africa), as well as the rest of the world, outside the U.S. In addition to EU markets, a worldwide regulatory filing program for ibrutinib is currently underway.

In the US, Imbruvica obtained approval to treat patients with MCL and CLL who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17 (del 17p), including treatment-naive and previously treated del 17p CLL patients.

The EC approval was based on data from the Phase 2 study (PCYC-1104) in MCL, the Phase 3 RESONATE™ study (PCYC-1112-CA) in CLL and small lymphocytic lymphoma (SLL) and the Phase Ib/II study (PCYC-1102) in CLL/SLL. This approval is based on the Imbruvica Marketing Authorization Application (MAA) submitted to the European Medicines Agency (EMA) last year.

In 2013 the NDA for Ibrutinib was placed on a priority basis by the FDA after a Phase 2 multicenter study of Ibrutinib was presented, and it identified a staggering 70% response rate from MCL patients with 68% of patients demonstrating an overall response rate after roughly nine months.

In June 2014, study results revealed Ibrutinib elicited a significant improvement for patients with either CLL or SLL in both overall survival and progression free survival in a study comparing it with Ofatumumab.

LGM Pharma is a provider of the APIs Ibrutinib, CAS # 936563-96-1 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Idelalisib EU Approval Granted For Treating CLL and FL Patients

Wednesday, September 24th, 2014

Idelalisib CAS 870281-82-6Gilead Sciences has been granted marketing authorization by the European Commission for its Idelalisib 150mg tablets (to be marketed as Zydelig) to treat the two incurable blood cancers Chronic Lymphocytic Leukemia (CLL) and Follicular Lymphoma (FL). This formidable first-in-class oral inhibitor of phosphoinositide 3-kinase (PI3K) delta, plays a key role in the activation, proliferation and viability of B cells, a critical component of the immune system.

The EU indications are similar, but not identical, to those in the U.S., where Idelalisib was approved in July 2014. For the treatment of CLL, the Idelalisib EU approval covers the use of Idelalisib combined with Rituximab for patients who have received at least one prior therapy (same as the US indication).

chronic lymphocytic leukemia (CLL)This Idelalisib EU approval was based mainly on a trial in 220 patients that was stopped early after it showed a significantly longer progression-free survival in patients receiving Idelalisib plus Rituximab. The results were published earlier this year in the New England Journal of Medicine. Researchers concluded that the addition of Idelalisib to Rituximab “provided effective durable disease control and improved overall survival for patients with relapsed CLL who were not suitable for cytotoxic chemotherapy, including high-risk patients.” Researchers also mentioned that treatment for CLL can be worse than the disease, leading to a great deal of side effects and death.

Idelalisib will be administered along with Rituximab for patients fighting refractory CLL. While there is a slight risk of serious toxicities, the majority of patients had common adverse reactions that were not deemed severe, and included pyrexia, abdominal pain, diarrhea, nausea and a mild rash. These adverse effects were seen in patients who were administered Idelalisib both with and without the addition of Rituximab.

Idelalisib is also EU approved to treat Follicular Lymphoma (FL) as monotherapy in patients who are refractory to two prior lines of treatment. This approval is supported by positive data from a phase 2 study of Idelalisib monotherapy in 125 patients.

The researchers concluded that Idelalisib “appears to provide effective oral monotherapy in patients with previously treated indolent non–Hodgkin’s lymphoma,” and these data were described as “eyebrow raising” when they were first presented at the 2103 American Society of Hematology meeting.

The advent of Idelalisib offers patients with these hard to treat forms of blood cancers better options for treatment and hope for tangible progression free survival. Idelalisib is also easy to administer as oral tablets which are typically taken twice daily, either with or without food. There are over 200,000 patients in the United States who suffer from relapsed follicular B-cell non-Hodgkin lymphoma, relapsed chronic lymphocytic leukemia or small lymphocytic lymphoma. This patient population is clearly in need of innovative and effective treatments.

LGM Pharma can assist clients as a supplier/distributor of Idelalisib, CAS # 870281-82-6, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Progression Free Survival Goal Met With Cobimetinib

Monday, August 11th, 2014

Vemurafenib and Cobimetinib- a Dynamic Duo in the Fight Against MelanomaImpressive news was revealed from Roche and Exelixis on June 14, 2014 with successful Phase III study results from their melanoma trial. This comprehensive trial involved Exelixis’s Cobimetinib and Zelboraf, which is marketed by Roche, for treating patients with advanced cases of melanoma. All of the 495 patients had specific mutations of the BRAF gene and many were considered to have unresectable cases of this deadly skin cancer. The surprise for clinical trial investigators came when they found the concomitant use of these two drugs led to a longer progression free survival for patients in comparison to their treatment with Zelboraf alone. These top line results are exciting for the medical and pharmaceutical community as this data clears the way for an upcoming FDA application. The Phase III study, coined coBRIM not only met its primary goal of progression free survival, thanks to the addition of Cobimetinib, but it also proved to be safe and tolerable.

Cobimetinib is a highly selective inhibitor of mitogen-activated protein kinase MEK, and has demonstrated efficacious ability sustain the inhibition of MEK in both mutant RAS and BRAF tumor models. The development of Cobimetinib is currently under Roche and Genentech, with a collaboration agreement with Exelixis. A successful Phase 1b dose escalation study of Cobimetinib, called BRIM7, proved this potent drug was effectual when used adjunctively with the BRAF inhibitor Vemurafenib. The BRIM7 study involved patients with metastatic cases of melanoma who had the BRAFV600 mutation, with the results being presented at the 10th European Association of Dermato-Oncology Congress in May 2014.

Clinical trials are ongoing for Cobimetinib alongside other anti-cancer agents, and many of the patients accepted in these trials are chosen specifically for their genetic mutations. Current studies include combining Cobimetinib with: GDC-0068, an AKT inhibitor; Onartuzumab, a MET targeting antibody; MEHD7945A, a biotherapeutic targeting EGFR and HER3; and GDC-0941, a PI3K inhibitor. This patient population is facing a critical need for new and innovative treatment, and Cobimetinib looks like it may be the agent to meet this need.

LGM Pharma is a provider of the API Cobimetinib, CAS # 934660-93-2 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

 

Tipiracil and Trifluridine Are Powerful Opponents Against Colorectal Cancer

Thursday, July 31st, 2014

Tipiracil and Trifluridine Are Powerful Opponents Against Colorectal CancerPositive findings were recently revealed from Taiho Oncology Inc. with the revelation of their global Phase 3 trial coined RECOURSE. This extensive trial was of the anticancer combination duo Tipiracil and Trifluridine, also called TAS-102. Data disseminated from this Phase 3 trial demonstrated that TAS-102 reduced the risk of mortality for patients with unresectable colon cancer by 32 percent as compared to a placebo. Clinical trial participants also achieved statistically sizable improvements in progression free and overall survival, including patients who were previously intolerant to former therapies. This inspiring data was presented at the European Society for Medical Oncology 16th World Congress on Gastrointestinal Cancer, which was held in Barcelona, Spain.

The RECOURSE trial included 800 patients that were randomized to receive best in care treatments either with or without the formidable TAS-102 combination treatment. All of the patients enrolled in this Phase 3 trial had completed on average two previous therapies which were deemed unsuccessful. Both the primary outcome measure of increased overall survival and secondary endpoint of progression-free survival were met.

The patient group who were administered Tipiracil and Trifluridine { TAS-102} gained an overall survival time of 7.1 months, as well as a 52 percent decrease in the risk of disease progression as compared to the placebo arm of the study. Clinically relevant results from the dynamic duo Tipiracil and Trifluridine clearly offered patients with refractory metastatic colon cancer a viable chance at extended survival. As efficacious antitumor agents both Tipiracil and Trifluridine have proven tolerable for and safe for patients in studies. Adverse effects were reported, but there were no participants who withdrew due to these effects. Most commonly reported side effects included diarrhea, anemia, leukopenia, vomiting, nausea, neutropenia and fatigue.

Colorectal Cancer Statistics

Colorectal cancer is the third most common cancer for American men and women. The American Cancer Society offers daunting statistics estimating that the lifetime risk of developing this potentially fatal disease is 1 in 20 people in the U.S. Approximately 96,830 new cases of colon cancer are diagnosed each year in the United States, along with roughly 40,000 new cases of rectal cancer. Estimates regarding the mortality of patients diagnosed with colon cancer are of great concern as well, with an estimated 50,310 fatalities predicted in 2014. Novel treatments which improve overall survival and extend progression free survival are critically necessary.

LGM Pharma is a provider of Trifluridine, CAS# 70-00-8, and Tipiracil, CAS# 183204-74-2 APIs for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Idelalisib FDA Approved to Combat Three Blood Cancers

Monday, July 28th, 2014

Idelalisib is FDA Approved Gilead has announced the July 23, 2014 Idelalisib FDA approved news. The Idelalisib (or the brand name Zydelig) approval was long awaited, to combat three forms of blood cancer. The FDA extended a nod to this powerful drug, which is estimated to earn roughly 1.2 billion dollars by the year 2020. Approved to treat three type of B-cell blood cancer, Idelalisib is effective for relapsed follicular B-cell non-Hodgkin lymphoma, relapsed chronic lymphocytic leukemia and small lymphocytic lymphoma. As a formidable first-in-class PI3k inhibitor Idelalisib will be administered along with Rituximab for patients fighting refractory chronic lymphocytic leukemia. While there is a slight risk of serious toxicities, the majority of patients had common adverse reactions that were not deemed severe, and included pyrexia, abdominal pain, diarrhea, nausea and a mild rash. These adverse effects were seen in patients who were administered Idelalisib both with and without the addition of Rituximab.

Phase III results were impressive for Zydelig {Idelalisib}, showing a response rate of 81 percent. When clinical study participants received both Idelalisib and Rituximab to treat refractory chronic lymphocytic leukemia patients gleaned a 93 percent progression-free survival rate at 24 weeks. The advent of Idelalisib offers patients with these hard to treat forms of blood cancers better options for treatment and hope for tangible progression free survival. Idelalisib is also easy to administer as oral tablets which are typically taken twice daily, either with or without food. There are over 200,000 patients in the United States who suffer from relapsed follicular B-cell non-Hodgkin lymphoma, relapsed chronic lymphocytic leukemia or small lymphocytic lymphoma. This patient population is clearly in need of innovative and effective treatments.

LGM Pharma can assist clients as a provider of Idelalisib, CAS # 870281-82-6, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.