Bristol-Myers Squibb Co.'s (BMY) cancer drug Opdivo has received FDA approval for yet another indication - this time for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. This marks the fifth approval for Opdivo across three distinct tumor types in 12 months, according to the company.
In a clinical trial, advanced renal cell carcinoma patients treated with Opdivo achieved a median Overall Survival of 25 months compared to 19.6 for Everolimus, a current standard of care.
The approval comes much ahead of projected FDA action date of March 16, 2016.
Opdivo was first approved for the treatment of advanced melanoma by the FDA last December. On March 4, 2015, Opdivo received its second FDA approval for the treatment of patients with advanced squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.
Last month, Opdivo in combination with Yervoy was approved by the FDA for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma and for the treatment of patients with metastatic non-squamous non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.
The drug is also approved in Japan for the treatment of patients with unresectable melanoma, and in Europe for advanced melanoma and advanced squamous non-small cell lung cancer.
Opdivo raked in sales of $305 million in Q3-2015.
BMY closed Monday's trading at $67.99, up 0.25%.
BioLineRx Ltd. (BLRX) has commenced a phase 1/2 trial for BL-8040, in combination with standard of care immunosuppressive therapy, as a novel treatment for two bone marrow failure conditions - hypoplastic myelodysplastic syndrome and aplastic anemia.
Interim results from the study are expected by end of 2016.
BLRX closed Monday's trading at $1.30, up 4.42%.
CTI BioPharma Corp. (CTIC) has initiated the rolling submission of its new drug application to the FDA for Pacritinib, an investigational oral kinase inhibitor, for the treatment of patients with myelofibrosis.
The company expects to complete the submission before the end of 2015.
CTIC closed Monday's trading at $1.20, up 9.09%.
CytRx Corp. (CYTR) has achieved its target enrollment of 28 patients with unresectable glioblastoma multiforme, a deadly form of brain cancer, in its phase II trial with Aldoxorubicin.
According to the company, Aldoxorubicin has shown evidence of tumor shrinkage, and overall survival has not yet been reached. Additionally, an advisory board of neuro-oncologists recently met to review the updated phase 2 results and concluded that Aldoxorubicin should be evaluated in combination with Avastin in patients with late-stage GBM.
CYTR closed Monday's trading at $3.00, down 5.36%.
Entellus Medical Inc. (ENTL) has received 510(k) clearance from the FDA for use of its XprESS Multi-Sinus Dilation System in pediatric patients, thereby expanding the patient population to include treatment of maxillary sinuses in patients 2 years and older, and treatment of the frontal and sphenoid sinuses in patients 12 years and older.
Chronic sinusitis affects approximately 29 million adults and approximately 6 million children in the United States, making it one of the most common health problems in the United States.
ENTL closed Monday's trading at $16.42, up 0.43%.
Idera Pharmaceuticals Inc. (IDRA) has entered into an exclusive worldwide collaboration and license agreement with GlaxoSmithKline plc (GSK) to identify 3rd generation antisense molecules for treatment of renal disease.
The agreement enables Idera to receive approximately $100 million in development and regulatory milestone payments, including a $2.5 million upfront payment. Additionally, Idera is eligible to receive royalties on all sales upon commercialization at varying rates up to five percent on annual net sales in excess of $500 million.
IDRA closed Monday's trading at $3.43, up 7.52%.
Shares of Summit Therapeutics plc (SMMT) were up over 13% on Monday following compelling results from a phase II proof of concept clinical trial that evaluated the company's novel, oral antibiotic, Ridinilazole against the current standard of care, Vancomycin, for the treatment of C. difficile infection.
In the phase II trial, dubbed CoDIFy, Ridinilazole achieved statistical superiority over Vancomycin in sustained clinical response - with SCR rates of 66.7% for Ridinilazole compared to 42.4% for Vancomycin.
SMMT closed Monday's trading at $10.88, up 13.93%.
Shares of XBiotech (XBIT) plunged 32% in extended trading on Monday after the company revealed a mess-up in execution of a phase III study of its lead product candidate Xilonix in colorectal cancer, being conducted under the European Medicines Agency regulatory path.
The co-primary endpoint of the trial was set as improvement in lean body mass and improvement in quality of life assessed after eight weeks of therapy, using whole body DEXA scanning for body composition assessment and the validated EORTC QLQ-C30 questionnaire for life quality assessment.
According to the company, there were irregularities in data from 72 patients in the study - as 25 patients dropped off study prior to receiving any dosing with drug or placebo, 14 patients erroneously received either placebo or study drug while 33 patients completed the study but failed to receive scheduled DEXA scans, properly complete EORTC evaluation, or both.
The company's pivotal U.S. colorectal cancer study being conducted under a Fast Track designation from the FDA is underway and is expected to complete enrollment by the end of 2016.
XBIT closed Monday's trading at $13.25, down 2.14%. In after hours, the stock was down another 32.08% to $9.00.
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