FDA Approves Omisirge Cell Therapy For Blood Cancers

RTTNews | 742 hari yang lalu

(RTTNews) - The U.S. Food and Drug Administration approved Gamida Cell Ltd.'s Omisirge (omidubicel-onlv) cell therapy for patients with blood cancers to reduce risk of infection following stem cell transplantation.

Gamida Cell shares gained around 39 percent on Monday's regular trading. The gain continued in the after hours trading with a further growth of 4 percent.

Omisirge is a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery of neutrophils, i.e., a subset of white blood cells, in the body and reduce the risk of infection.

The product is intended for use in adults and pediatric patients 12 years and older with blood cancers planned for umbilical cord blood transplantation following a myeloablative conditioning regimen, treatment such as radiation or chemotherapy.

The Omisirge application received Priority Review, Breakthrough Therapy and Orphan designations.

Blood cancers are caused by uncontrolled growth of cells in the blood, disrupting the ability of blood cells to perform their normal functions.

Stem cell transplantation, which involves putting healthy stem cells into the body to help restore the normal production and function of blood cells, is a common treatment for blood cancers. One source of healthy stem cells is umbilical cord blood.

Omisirge, administered as a single intravenous dose, is composed of human allogeneic stem cells from umbilical cord blood that are processed and cultured with nicotinamide, a form of vitamin B3.

The FDA approval was based on the safety and effectiveness of Omisirge that was supported by a randomized, multicenter study comparing transplantation of Omisirge to transplantation of umbilical cord blood, in subjects between the ages of 12 and 65 years. All of 125 subjects in the study had confirmed blood cancers.

The agency noted that the efficacy of Omisirge was based on the amount of time needed for recovery of the subject's neutrophils, and the incidence of infections following transplantation.

In the trial, 87 percent of subjects who were randomized to receive Omisirge achieved neutrophil recovery with a median of 12 days following treatment with the product. This was compared to 83% of subjects who were randomized to receive umbilical cord blood transplantation and who achieved neutrophil recovery with a median of 22 days.

Further, the FDA warned that treatment with Omisirge has the potential to cause severe side effects, which must be considered in assessing the risks and benefits of using this product.

Similar to all approved umbilical cord products, the label carries a Boxed Warning for infusion reactions, graft versus host disease, engraftment syndrome, and graft failure.

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said, "Today's approval is an important advance in cell therapy treatment in patients with blood cancers," said "Hastening the return of the body's white blood cells can reduce the possibility of serious or overwhelming infection associated with stem cell transplantation."

For More Such Health News, visit rttnews.com

Teg: GMDA

Gamida Cell Appoints Abigail Jenkins To Succeed Julian Adams As President And CEO

Gamida Cell Ltd. (GMDA) announced Monday that Abigail "Abbey" Jenkins, has joined as President & CEO. Jenkins has also been appointed to Gamida Cell's Board of Directors. Jenkins succeeds Julian Adams, who is retiring in accordance with planned succession and will continue to serve on the company's Board of Directors.

RTTNews | 952 hari yang lalu

Australian Market Strongly Adds To Early Gains In Mid-market

The Australian stock market is strongly extending its early modest gains in mid-market trading on Tuesday, adding to the gains in the previous three sessions, following the mixed cues from Wall Street overnight. The benchmark S&P/ASX 200 is moving well above the 8,000 mark, with gains across most sectors led by iron ore miners, technology and energy stocks.

RTTNews | 18 minit yang lalu

Asian Markets Trade Mostly Higher

Asian stock markets are trading mostly higher on Tuesday, following the mixed cues from Wall Street overnight, as traders remain optimistic and keep a close eye on developments on the tariff front, with US Treasury Secretary Scott Bessent reportedly said he believes an agreement in principle can reached on "17 or 18 important trade deals" the administration is currently negotiating.

RTTNews | 42 minit yang lalu

Sensex, Nifty Likely To See Muted Start

Indian shares may open on a flat note Tuesday as investors react to macroeconomic data as well as reports suggesting that U.S. President Donald Trump may consider giving automakers a break on some of his tariffs.

RTTNews | 1j 8min yang lalu

Thai Stock Market Has Flat Lead

The Thai stock market has moved higher in two straight sessions, gathering more than a dozen points or 1 percent along the way. The Stock Exchange of Thailand now sits just beneath the 1,160-point plateau and it's expected to be rangebound again on Tuesday. The global forecast for the Asian markets is mixed with a touch of upside amidst a lack of catalysts. The European markets were up slightly and the U.S. bourses were mixed and little changed and the Asian markets figure to split the difference. The SET finished barely higher on Monday as gains from the food, finance, resource and technology stocks were capped by weakness from the consumer, industrial, property and service sectors. For the day, the index rose 0.53 points or 0.05 percent to finish at 1,159.53 after trading between 1,156.63 and 1,166.32. Volume was 5.368 billion shares worth 28.497 billion baht. There were 250 decliners and 216 gainers, with 188 stocks finishing unchanged. Among the actives, Advanced Info added 0.36 percent, while Thailand Airport retreated 0.68 percent, Asset World sank 0.90 percent, Banpu gained 0.47 percent, Bangkok Bank collected 0.74 percent, Bangkok Dusit Medical tumbled 1.70 percent, Bangkok Expressway picked up 0.84 percent, B. Grimm strengthened 0.89 percent, BTS Group declined 0.81 percent, CP All Public lost 0.50 percent, Charoen Pokphand Foods advanced 0.97 percent, Energy Absolute slumped 0.91 percent, Gulf gathered 0.55 percent, Kasikornbank rose 0.32 percent, Krung Thai Bank climbed 0.96 percent, PTT Oil & Retail surged 4.58 percent, PTT rallied 0.82 percent, PTT Exploration and Production was up 0.50 percent, PTT Global Chemical stumbled 2.82 percent, SCG Packaging tanked 2.21 percent, Siam Commercial Bank improved 0.86 percent, Siam Concrete dropped 0.99 percent, True Corporation shed 0.84 percent, TTB Bank increased 1.13 percent and Krung Thai Card and Thai Oil were unchanged.

RTTNews | 2j 23min yang lalu

Indonesia Shares Tipped To Open In The Red

The Indonesia stock market has moved higher in back-to-back sessions, advancing almost 110 points or 1.8 percent along the way. The Jakarta Composite Index now rests just above the 6,720-point plateau although it's expected to open to the downside on Tuesday. The global forecast for the Asian markets is mixed with a touch of upside amidst a lack of catalysts. The European markets were up slightly and the U.S. bourses were mixed and little changed and the Asian markets figure to split the difference. The JCI finished modestly higher on Monday following gains from the financial shares and mixed performances from the cement companies and resource stocks. For the day, the index added 44.05 points or 0.66 percent to finish at 6,722.97 after trading between 6,688.78 and 6,736.86. Among the actives, Bank CIMB Niaga fell 0.29 percent, while Bank Mandiri collected 0.41 percent, Bank Danamon Indonesia improved 0.83 percent, Bank Negara Indonesia dipped 0.24 percent, Bank Central Asia spiked 2.03 percent, Bank Rakyat Indonesia accelerated 2.67 percent, Indosat Ooredoo Hutchison rose 0.27 percent, Semen Indonesia skidded 1.15 percent, Indofood Sukses Makmur shed 0.67 percent, United Tractors dropped 0.87 percent, Astra International added 0.62 percent, Energi Mega Persada rallied 1.59 percent, Astra Agro Lestari jumped 1.71 percent, Aneka Tambang shed 0.47 percent, Timah soared 3.52 percent, Bumi Resources tumbled 1.87 percent and Vale Indonesia and Indocement were unchanged.

RTTNews | 2j 24min yang lalu

Steady Start Tipped For Hong Kong Stock Market

The Hong Kong stock market has moved lower in two of three trading days since the end of the three-day winning streak in which it had jumped more than 1,000 points or 4.5 percent. The Hang Seng Index now sits just above the 21,970-point plateau and it may tick slightly higher on Tuesday. The global forecast for the Asian markets is mixed with a touch of upside amidst a lack of catalysts. The European markets were up slightly and the U.S. bourses were mixed and little changed and the Asian markets figure to split the difference.

RTTNews | 2j 24min yang lalu

China Shares Likely To Remain Rangebound

The China stock market has finished lower in two straight sessions, sliding more than 10 points or 0.3 percent along the way. The Shanghai Composite Index now sits just beneath the 3,290-point plateau and it's likely to hold steady in that neighborhood again on Tuesday. The global forecast for the Asian markets is mixed with a touch of upside amidst a lack of catalysts. The European markets were up slightly and the U.S. bourses were mixed and little changed and the Asian markets figure to split the difference.

RTTNews | 2j 25min yang lalu

EURUSD	1.13946	GBPUSD	1.34144	AUDUSD	0.64171
USDJPY	142.384	USDCAD	1.38565	USDCHF	0.82327

Advertisement

FDA Approves Omisirge Cell Therapy For Blood Cancers