Carfilzomib Shines in Studies of Patients with Relapsed Myeloma

carfilzomibCarfilzomib shined in pharmaceutical headlines recently with encouraging study data being shared in June 2015. Known as the brand name anticancer therapy Kyprolis, which is marketed by Onyx, the Carfilzomib injection proved to be superior to a Bortezomib-Dexamethasone combination treatment in patients with refractory multiple myeloma. Carfilzomib is an effectual single-agent therapy and proteasome inhibitor which in studies doubled progression free survival time in patients suffering from relapsed multiple myeloma. When compared to a combination therapy of Bortezomib and Dexamethasone, a higher dose of Carfilzomib then currently approved elicited an average progression free survival time of 18.7 months versus 9.4 months, respectively. Being that the standard best in care therapy for patients with unresectable multiple myeloma is currently Bortezomib and Dexamethasone, this new information regarding Carfilzomib efficacy offers new hope for the many patients who seek longer and better quality progression free survival time.

Myeloma AgeThe FDA approved dosage of Carfilzomib is 20 milligrams on days one and two of the first cycle, followed by a dosage of 27 milligrams daily thereafter to be infused in a two to ten minute time frame. Data from phase a first-ever phase III randomized study compared Carfilzomib with the standard therapy of Bortezomib, with both groups of patients also receiving Dexamethasone. In total 929 patients were dosed with Carfilzomib 20/56 mg/m2 via a 30 minute infusion or Bortezomib 1.3 mg/m2, via a subcutaneous injection or intravenously. All patients also received 20 milligrams daily of Dexamethasone. The patient population who were dosed with Carfilzomib regimen had it administered in 28-day cycles versus a 21-day cycle of treatment for the patients who were given Bortezomib. Roughly 15 percent of the patients enrolled in this study were older than age 75, but the average age for all of the participants was 65 years of age. A 47 percent reduction in hazard for disease progression or mortality was established for patients who were administered Carfilzomib and Dexamethasone, with twice as many participants achieving a complete response as compared the Bortezomib patient group. While grade 3 adverse events did occur with patients in both study groups, the most frequently reported side effects included fatigue, diarrhea, dyspnea and pyrexia.

LGM Pharma can assist clients as a supplier/distributor of the API Carfilzomib, CAS # 868540-17-4 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

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Gemcitabine and Cisplatin Continue as Successful Therapy for Patients with NSCLC

Gemcitabine and Cisplatin

Patients with non-small cell lung cancer, also known as NSCLC, are anxiously awaiting a decision from the FDA’s Oncologic Drugs Advisory Committee regarding Eli Lilly’s introduction of Necitumumab to the already formidable Gemcitabine and Cisplatin combination. Both Gemcitabine and Cisplatin are currently the first line-treatment for patients diagnosed with NSCLC, and the addition of Necitumumab looks to be a promising happening on the horizon. Not only was the addition of Necitumumab to the Gemcitabine and Cisplatin pair tolerable in studies, overall survival rates significantly improved with the new trio of treatments.

Results from the successful phase III clinical trial which combined Gemcitabine, Cisplatin and Necitumumab have been encouraging. Approximately 1,093 patients were enrolled in this landmark study, which demonstrated a median overall survival time of 11.5 months for patients treated with all three drugs. Compared to patients who were dosed with Gemcitabine and Cisplatin only, there was a definite improvement in overall survival rates- 11.5 months versus 9.9 months, respectively. The aforementioned study, coined SQUIRE, included 184 investigative sites in 26 countries. All of the patients in the study had stage IV squamous NSCLC and were admitted to the study, regardless of their EGFR mutation status. A 3-week schedule is most often administered when dosing both Gemcitabine and Cisplatin, and this was the case in the SQUIRE study. Of the 1,093 patients, 545 patients were randomized to receive Gemcitabine and Cisplatin plus Necitumumab and 548 patients were dosed Gemcitabine and Cisplatin only. Exactly 800 milligrams of Necitumumab was administered to patients on day 1 and 8 every 3 weeks. In both groups Gemcitabine was dosed at 1250 mg/m2 on days 1 and 8 and 75 mg/m2 of Cisplatin was given on day 1 only. Patients were balanced in both of the study arms, with statistical data revealing an average participant age of 62, with 84 percent of patients being of the Caucasian ethnicity and 91 percent of people being smokers. More information will be presented in September 2015 at the 16th World Conference on Lung Cancer.

As the most commonly diagnosed form of lung cancer NSCLC accounts for roughly 85 percent of all lung cancer patients. The squamous form of NSCLC is less common, and effects less patients, but is much more difficult to treat effectively. Unfortunately the majority of patients are diagnosed with squamous NSCLC when the disease has progressed extensively, leaving an average five year survival rate of less than five percent. Further R&D is needed using the effectual Gemcitabine and Cisplatin products.

LGM Pharma can assist clients as a supplier/distributor of the APIs Gemcitabine, CAS # 95058-81-4 and Cisplatin CAS #15663-27-1 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

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Sonidegib FDA Approved as Once Daily Treatment for Locally Advanced Basal Cell Carcinoma

Sonidegib FDA Approved for Locally Advanced Basal Cell CarcinomaOn July 24, 2015 the FDA approved Sonidegib, marketed by Novartis AG as the once daily pill Odomzoa for the treatment of locally advanced basal cell carcinoma. Specifically for patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy.

Sonidegib, also known as the compound LDE225, had recently captured the attention of the pharmaceutical and medical industry worldwide, due to extremely successful study data. Conducted by Novartis, the reports from a Phase 2 study have shown Sonidegib to be a top-notch drug, eradicating basal cell carcinoma in a number of patients. Dispensed as an oral treatment for patients suffering from advanced basal cell carcinoma, the study results easily met the primary endpoint, garnishing an objective response rate within six months’ time. The objective response was based on the criteria of the complete absence of advanced basal cell carcinoma, and clinically sizable tumor shrinkage. The pharmaceutical industry was poised for an earlier than planned FDA application from Novartis, based on these incredible Phase 2 results.

smoothendAs an effectual drug that inhibits a receptor coined smoothened, that regulates the hedgehog signaling pathway, Sonidegib efficiently and safely blocks tumor growth. With basal cell carcinoma accounting for over 80 percent of non-melanoma cancers, treatments for advanced stages of this form of skin cancer are urgently needed. The advent of an easy to dispense oral treatment to fight this now common cancer worldwide offers hope for a greater number of patients. Around the world there is a 10 percent incident increase of basal cell carcinoma every year, which is likely due to an aging population and greater exposure to dangerous ultraviolet rays. Basal Cell Carcinoma does not often metastasize, but more advanced cases of this regularly seen disease are manifesting. The exciting data gleaned from Novartis’s study of Sonidegib showcasing patients who achieved complete remission is nothing short of miraculous.

LGM Pharma provides Sonidegib CAS# 956697-53-3, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

 

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Caspofungin Therapy Aids ALL Patients with Invasive Fungal Disease

caspofunginExciting news was shared in the January 2015 issue of Mycoses, with clinical data revealing that the use of Caspofungin to treat invasive fungal disease in leukemia patients was both positive and responsive. Adult patients who were diagnosed with acute lymphoblastic leukemia attained relief from their suspected fungal disease after the clinical use of Caspofungin. As an effectual member of the echinocandin drug class Caspofungin is often used in patients who have not responded to prior antifungal treatments. Caspofungin has, however, proved to be widely effective for treating an array of serious fungal infections, particularly in immunocompromised patients such as the patient population aforementioned. The administration of Caspofungin is done intravenously, with a typical dosage being dispensed slowly over a one hour period. Side effects can sometimes include nausea, diarrhea, and headache and skin flushing.

The risk of invasive and life-threatening fungal disease is specifically common in patients with acute lymphoblastic leukemia (ALL). This patient group will be at a greater risk for this virulent fungal disease typically after either a hematopoietic stem cell transplantation or cytotoxic chemotherapy. Data gleaned from the study shared in Mycoses showed that when patients with ALL who received Caspofungin empirically attained treatment that was deemed therapeutically effective. Nine medical centers in Germany participated in the ALL/Caspofungin data analysis, with information being collected between 2006 and 2012. Therapy duration of at least 8 days of treatment with Caspofungin in these patients with suspected invasive fungal disease proved that 95 percent of patients attained efficacy, including those patients who were considered critically ill.

LGM Pharma can assist clients as a supplier/distributor of the API Caspofungin, CAS #162808-62-0 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

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Positive Opinion from the EU for Bevacizumab as Cervical Cancer Treatment

BevacizumabKnown as the blockbuster brand name anticancer therapy Avastin, Bevacizumab recently captured a positive opinion from the EU for its success in treating cervical cancer. On March 2, 2015 Roche Pharmaceuticals announced that the European Union’s (EU) Committee for Medicinal Products for Human Use expressed a positive opinion of Bevacizumab when used alongside standard chemotherapy for the treatment of cervical cancer. Studies of Bevacizumab, used in combination with either Paclitaxel and Cisplatin or Paclitaxel and Topotecan, in patients who were unable to receive platinum therapy, proved to be effectual for treating adult females with metastatic carcinoma of the cervix. With an estimated 33,000 new cases of cervical cancer predicted to be diagnosed in the EU in 2015, as well as one third of these patients not surviving this virulent disease, an anticipated approval of Bevacizumab as a therapy for cervical cancer is hopeful. The FDA already approved Bevacizumab in the United States for the treatment of recurrent and metastatic cervical cancer in August 2014. Bevacizumab is currently approved in the EU to treat advanced stages of breast cancer, non-small cell lung cancer, colorectal cancer, ovarian cancer and kidney cancer. The U.S. has approved the additional indications of cervical cancer and progressive glioblastoma following prior therapy for Bevacizumab.

As an effective anticancer medication that interferes with both the spread and growth of cancer cells Bevacizumab is typically given as part of a combination of treatments for cancer patients. Bevacizumab is dispensed intravenously about once every two weeks. While adverse effects can occur from Bevacizumab, such as excess bleeding and difficulty with wound healing, many patients experience tolerable side effects. Reported negative effects from Bevacizumab include body aches, bleeding gums, diarrhea, dizziness and tingling in the limbs.

Studies leading to the FDA approval of Bevacizumab in 2014 and the positive opinion from the EU in March of 2015 offered encouraging data for treating patients with cervical cancer. Initial survey results from studies with Bevacizumab were presented in 2013 at the American Society of Clinical Oncology annual meeting, which showed that patients with metastatic cervical cancer who were administered Bevacizumab lived an average of 3.7 months longer than their counterparts who did not receive this formidable drug. The aforementioned clinical trial, coined GOG240, was sponsored by the National Cancer Institute. The median age of patients was 47 years old and the approximate dose of Bevacizumab was 15 milligrams per kilogram (mg/kg) of their body weight via an intravenous drip. Treatment continued for patients one day every three weeks and was dispensed along with other chemotherapeutic drugs. Progression-free survival was 8.2 months for those patients who were given Bevacizumab, as compared to 5.9 months of progression –free survival for patients who were not administered Bevacizumab. By blocking the blood supply that feeds the tumors Bevacizumab is efficacious for both binding and inhibiting vascular endothelial growth factor. LGM Pharma can assist clients as a supplier/distributor of the API Bevacizumab CAS# 216974-75-3 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

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