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Lorbrena Accredited for Beforehand-Handled ALK-Constructive Metastatic NSCLC

Posted in News on 6th November 2018

November 05, 2018

Lorbrena is a third generation ALK tyrosine kinase inhibitor

Lorbrena is a third generation ALK tyrosine kinase inhibitor

Pfizer announced that the Food and Drug Administration (FDA) has approved Lorbrena (lorlatinib) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on: crizotinib and at least 1 other ALK inhibitor for metastatic disease; or alectinib as the first ALK inhibitor therapy for metastatic disease; or ceritinib as the first ALK inhibitor therapy for metastatic disease. 

Lorbrena, a third generation ALK tyrosine kinase inhibitor (TKI), has been approved under the accelerated pathway based on tumor response rate and duration of response. Continued approval may be based on verification and description of clinical benefit in a confirmatory trial. 

The FDA approval was supported by data from a non-randomized, dose-ranging and activity-estimating, multi-cohort, multicenter Phase 1/2 study that evaluated Lorbrena in patients with ALK-positive metastatic NSCLC who were previously treated with 1 or more ALK TKIs (N=215) . 

Results showed an overall response rate (ORR) of 48% (95% CI, 42%, 55%) among treated patients (4% complete response; 44% partial response); 57% of patients had previous treatment with >1 ALK TKI. The median duration of response was 12.5 months (95% CI, 8.4, 23.7). In addition, an assessment of intracranial ORR showed a 60% response rate (95% CI, 49%, 70%) among patients with measurable intracranial lesions; 69% of patients had a history of brain metastases. The median duration of response in these patients was 19.5 months (95% CI, 12.4, not reached [NR]). 

The most frequent adverse reactions reported with treatment included edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea. 

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“Lorbrena’s approval is an important milestone for patients, having demonstrated marked activity in a study that included a broad range of individuals with ALK-positive non-small cell lung cancer. This includes patients who were heavily pretreated and facing limited options after receiving first- and second-generation ALK tyrosine kinase inhibitors,” stated Mace Rothenberg, MD, Chief Development Officer, Oncology, Pfizer Global Product Development.

Lorbrena will be available as 25mg and 100mg strength tablets in 30-count bottles.

For more information call (800) 438-1985 or visit Lorbrena.com.

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Section III CLL14 examine evaluating Venclexta plus Gazyva to deal with CLL meets its major endpoint

Posted in News on 5th November 2018

Genentech, a member of the Roche Group , introduced as we speak that the randomized Section III CLL14 examine, which evaluated fixed-duration Venclexta® (venetoclax) together with Gazyva® (obinutuzumab) in folks with beforehand untreated power lymphocytic leukemia (CLL) and co-existing medical circumstances, met its major endpoint and confirmed a statistically vital discount within the danger of illness worsening or dying (progression-free survival [PFS] as assessed by investigator) in comparison with standard-of-care Gazyva plus chlorambucil. The outcomes confirmed that no new security alerts or enhance in identified toxicities of Venclexta or Gazyva have been noticed with the remedy mixture.

“Individuals with power lymphocytic leukemia proceed to want extra remedy choices as a result of some sufferers are unable to tolerate chemotherapy regimens as a result of their underlying well being,” mentioned Sandra Horning, M.D., chief medical officer and head of International Product Growth. “CLL14 is the primary examine to point out superior progression-free survival for Venclexta plus Gazyva in comparison with a standard-of-care routine. We are going to work with well being authorities to deliver this potential chemotherapy-free remedy choice to individuals who want it as shortly as doable.”

Knowledge from the CLL14 examine shall be submitted to world well being authorities. Venclexta together with Rituxan® (rituximab) has been permitted by the U.S. Meals and Drug Administration (FDA) for the remedy of individuals with CLL or small lymphocytic lymphoma, with or with out 17p deletion, who’ve obtained at the very least one prior remedy. A supplemental New Drug Software (sNDA) is at the moment underneath assessment by the FDA for Venclexta together with a hypomethylating agent or together with low dose cytarabine for the remedy of individuals with beforehand untreated acute myeloid leukemia (AML) who’re ineligible for intensive chemotherapy, with a call anticipated by finish of 12 months.

A strong medical growth program for Venclexta is ongoing in a number of kinds of blood most cancers, together with AML and a number of myeloma. Gazyva continues to be investigated together with permitted and investigational molecules in CLL and follicular lymphoma.

Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It’s collectively commercialized by the businesses in the USA and commercialized by AbbVie outdoors of the USA.



Posted in: Drug Trial Information | Medical Situation Information

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FDA Clears Affected person Controller Platform for Stimwave’s Neuromodulation Machine

Posted in News on 5th November 2018
WaveCrest Mobile allows a patient to use an iPhone, iPod touch, or Apple Watch to adjust their pain relief therapy

WaveCrest Mobile allows a patient to use an iPhone, iPod touch, or Apple Watch to adjust their pain relief therapy

The Food and Drug Administration has cleared the WaveCrest Mobile iOS Platform for patients with Stimwave’s Wireless Freedom Spinal Cord Stimulator (SCS) System, allowing them to control their pain relief therapy through an iPhone or Apple Watch. 

The Stimwave SCS System utilizes a tiny injectable microchip device that sends small pulses of energy to electrodes near surrounding nerves. This elicits a reaction that allows the remapping of specific pain signals, thus resulting in pain relief. The device is implanted under the skin in an outpatient procedure. “The Freedom System not only is the smallest option available for patients eliminating the complexities of an implanted lithium ion battery, but offers a wide variety of advanced programming features that the patient can choose through their mobile device,” said Dr. Ellen Lin, MD, medical director of San Antonio’s Advanced Spine and Pain Center.

The new software enables patients to fine-tune the power level and modify programs that were pre-programmed by their clinician to control pain. 

Part 2 STEMTRA trial utilizing SB623 cells for treating traumatic mind harm meets major endpoint

Posted in News on 4th November 2018

The SanBio Group (SanBio Co., Ltd. and subsidiary SanBio Inc.; collectively, the “Firm”) proclaims as we speak that the Part 2 STEMTRA trial utilizing SB623 cells for the remedy of sufferers with traumatic mind harm (TBI), met its major endpoint.

This STEMTRA research confirmed that TBI sufferers with continual motor deficits handled with SB623 cells demonstrated a statistically vital enchancment of their motor operate in comparison with the management group, primarily based on the Fugl-Meyer Motor Scale (FMMS). The research met its major endpoint, with SB623 sufferers attaining a median eight.7 level enchancment from baseline within the FMMS, versus 2.four within the management group, at 24 weeks. The protection information confirmed that SB623 was nicely tolerated and no new security alerts had been recognized.

“This international medical trial, the most important stem cell research ever performed for TBI, is particularly thrilling given the rigor of its randomized double-blind design and demonstration of serious enchancment in motor operate for a lot of sufferers handled with SB623 cells,” stated Damien Bates MD, PhD, Chief Medical Officer and Head of Analysis at SanBio Group. “It is a vital milestone for regenerative medication and for a lot of sufferers affected by persistent disabilities brought on by TBI.” Primarily based on this research, SanBio Group goals to file for advertising and marketing approval in Japan within the fiscal 12 months ending January 2020.

The result of this research is prone to have minimal influence on the earnings of SanBio Group for the present fiscal 12 months. Nonetheless, SanBio Group believes that it’s going to enhance the Firm’s earnings within the medium to long run.



FDA: Class I Recall of Check Strips Because of Inaccurate INR Outcomes

Posted in News on 4th November 2018

November 02, 2018

The Agency has received approximately 90 medical device reports

The Agency has received approximately 90 medical device reports

Roche Diagnostics has issued a recall of certain lots of CoaguChek XS PT Test Strips, as these test strips may provide inaccurate results when used with CoaguChek test meter devices to monitor levels of warfarin. The Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall, meaning that use of the device may cause serious injuries or death.

Over 1.1 million packages of test strips distributed from January 12, 2018 to October 29, 2018 are being recalled. The full list of lot numbers can be found here.

“These strips are widely used and we are working diligently to warn healthcare providers and the public about the dangers associated with this recall. Using faulty strips can lead to serious errors in medication dosage that could cause serious harm or death in some patients,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “We are also working with the company on the swift removal of the recalled strips and to ensure the new corrected strips are distributed to patients and healthcare providers as quickly as possible.”

Medical device reports submitted by Roche Diagnostics to the FDA indicate that the test strips may provide higher than actual INR (International Normalized Ratio) results which could potentially lead to inaccurate warfarin dosing. The Agency has received approximately 90 medical device reports; 2 serious patient injuries involving strokes have been reported.

Roche Diagnostics stated in a press release that the problem was caused by “a recent re-calibration of the test strips to a different international standard that occurred earlier this year.” The Company will be providing new batches of re-calibrated test strips, based on the previous international standard, by the end of November; these test strips are used with the CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS professional, CoaguChek XS PST and CoaguChek Vantus test meter devices.

The FDA is urging healthcare providers to report all INR test meter problems to MedWatch. At this time, clinicians who have been using the recalled test strips should not rely on the CoaguChek meter results to determine whether warfarin dosing is appropriate.

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For more information visit FDA.gov.

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