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Gilead's (GILD) CAR T Cell Therapy Tecartus Wins EC Nod
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Gilead Sciences, Inc.’s (GILD - Free Report) company, Kite, announced that the European Commission has granted conditional marketing authorization to chimeric antigen receptor (CAR) T cell therapy, Tecartus (formerly KTE-X19), for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
Tecartus is an autologous, anti-CD19 CAR T cell therapy, which is an individualized method of treatment that harnesses the body’s own immune system to target cancer cells. The conditional authorization is generally granted to treatments for the welfare of public health, whereby immediate availability outweighs the risk of less comprehensive data available.
Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma that arises from cells originating in the “mantle zone” of the lymph node and predominantly affects men over the age of 60.
The authorization was supported by positive data from the multinational, single-arm, phase II, open-label ZUMA-2 pivotal study. The study demonstrated an overall response rate (complete or partial) of 93% in patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a BTK inhibitor. In the study, 67% of patients achieved a complete response, as assessed by an Independent Radiologic Review Committee following a single infusion of Tecartus.
In the safety analyses, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were observed in 15% and 33% of patients, respectively. The FDA granted accelerated approval to Tecartus in July 2020 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
We note that Gilead’s Yescarta, a CAR T cell therapy, is already approved for relapsed or refractory large B-cell lymphoma.
However, competition is stiff in the CAR T cell therapy space from the likes of Novartis’ (NVS - Free Report) Kymriah.
Gilead’s shares have lost 9.3% in the year so far against the industry’s growth of 8.4%.
The massive decline in sales of its HCV franchise has prompted it to focus on the HIV franchise, Yescarta and other newer avenues. Competition is stiffening in the HIV space as well from the likes of Glaxo (GSK - Free Report) . Hence, Gilead is diversifying into the oncology space.
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
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Gilead's (GILD) CAR T Cell Therapy Tecartus Wins EC Nod
Gilead Sciences, Inc.’s (GILD - Free Report) company, Kite, announced that the European Commission has granted conditional marketing authorization to chimeric antigen receptor (CAR) T cell therapy, Tecartus (formerly KTE-X19), for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
Tecartus is an autologous, anti-CD19 CAR T cell therapy, which is an individualized method of treatment that harnesses the body’s own immune system to target cancer cells. The conditional authorization is generally granted to treatments for the welfare of public health, whereby immediate availability outweighs the risk of less comprehensive data available.
Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma that arises from cells originating in the “mantle zone” of the lymph node and predominantly affects men over the age of 60.
The authorization was supported by positive data from the multinational, single-arm, phase II, open-label ZUMA-2 pivotal study. The study demonstrated an overall response rate (complete or partial) of 93% in patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a BTK inhibitor. In the study, 67% of patients achieved a complete response, as assessed by an Independent Radiologic Review Committee following a single infusion of Tecartus.
In the safety analyses, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were observed in 15% and 33% of patients, respectively. The FDA granted accelerated approval to Tecartus in July 2020 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
We note that Gilead’s Yescarta, a CAR T cell therapy, is already approved for relapsed or refractory large B-cell lymphoma.
However, competition is stiff in the CAR T cell therapy space from the likes of Novartis’ (NVS - Free Report) Kymriah.
Gilead’s shares have lost 9.3% in the year so far against the industry’s growth of 8.4%.
The massive decline in sales of its HCV franchise has prompted it to focus on the HIV franchise, Yescarta and other newer avenues. Competition is stiffening in the HIV space as well from the likes of Glaxo (GSK - Free Report) . Hence, Gilead is diversifying into the oncology space.
Gilead currently carries a Zacks Rank #4 (Sell). A better-ranked stock in the biotech space is Repligen (RGEN - Free Report) , which sports a Zacks Rank #1 (Strong Buy), presently. You can see the complete list of today’s Zacks #1 Rank stocks here.
These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
See the 5 high-tech stocks now>>