RHIZEN-PHARMACEUTICALS
Rhizen Pharmaceuticals, a clinical-stage oncology-focused biopharmaceutical company, today announced that its novel next generation PI3K-delta inhibitor, Umbralisib, which was licensed to TG Therapeutics (NASDAQ:TGTX), has secured US FDA accelerated approval for the treatment of:
- adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen, and
- adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.
Accelerated approval was granted for these indications, under a priority review (MZL), based on the results of the Phase 2 UNITY-NHL Trial (NCT02793583); in MZL, an ORR of 49% with 16% complete responses and in FL an ORR of 43% with 3% complete responses were achieved, respectively. Umbralisib was earlier granted Breakthrough Therapy Designation (BTD) for the treatment of MZL and orphan drug designation (ODD) for the treatment of MZL and FL.
Umbralisib is a novel, next generation, oral, once daily, inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon and was discovered by Rhizen Pharma and subsequently licensed to TG Therapeutics (NASDAQ:TGTX) at an IND stage (TGR 1202) in 2012. In 2014, both parties entered into a licensing agreement as a part of which TGTX obtained worldwide rights and Rhizen has retained commercialization rights for India while also being the manufacturing and supply partner for Umbralisib.
Swaroop Vakkalanka, President & CEO of Rhizen Pharmaceuticals said: “Umbralisib’s approval offers MZL & FL patients a new treatment option and is a huge validation of Rhizen’s drug discovery & development capabilities. This is a momentous occasion in Rhizen’s journey as a successful biotech that speaks of the true ability of our team to discover & develop safe and effective therapies that can last the rigors of drug development. Further, we are keen to bring Umbralisib to Indian patients and we plan to initiate activities towards registration and approval there soon.”
Pranav Amin, Chairman, Rhizen Pharmaceuticals & Managing Director of Alembic Pharmaceuticals Ltd said: “We are extremely proud of this historic milestone for Rhizen, and of the fact that Umbralisib is the first NCE discovered by Indian scientists to secure a US FDA approval. We are committed to working together with TG Therapeutics and Rhizen Pharma to ensure uninterrupted supply of UKONIQ™. Umbralisib is the first discovery asset to come out of Rhizen’s R&D efforts and this approval heralds the promise of the rest of Rhizen’s deep pipeline and continuing efforts.”
About Umbralisib:
Umbralisib is the first and only oral inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon. PI3K-delta is known to play an important role in supporting cell proliferation and survival, cell differentiation, intercellular trafficking and immunity and is expressed in both normal and malignant B-cells. CK1-epsilon is a regulator of oncoprotein translation and has been implicated in the pathogenesis of cancer cells, including lymphoid malignancies. Umbralisib is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. These indications are approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. More information on Umbralisib or UKONIQ™ can be found at https://www.tgtherapeutics.com/prescribing-information/uspi-ukon.pdf .
About Alembic Pharmaceuticals Ltd:
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic’s products that are marketed through a marketing team of over 5000 are well recognized by doctors and patients.
Information about Alembic can be found at http://www.alembicpharmaceuticals.com/ .
(Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLL TD) (BSE: 533573)
About Rhizen Pharmaceuticals A.G.:
Rhizen Pharmaceuticals is an innovative, clinical-stage biopharmaceutical company focused on the discovery and development of novel onco-therapeutics. Since its establishment in 2008, Rhizen has created a diverse pipeline of proprietary drug candidates targeting several cancers and immune associated cellular pathways. Rhizen is headquartered in Basel, Switzerland. For additional information, please visit www.rhizen.com .
View source version on businesswire.com: https://www.businesswire.com/news/home/20210208005742/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Incyte Announces Phase 1 Results for its TGFβR2×PD-1 Bispecific Antibody in Advanced Colorectal Cancer and KRAS G12D Inhibitor in Advanced Pancreatic Ductal Adenocarcinoma19.10.2025 19:30:00 CEST | Press release
Data presented at ESMO 2025 show INCA33890, a TGFβR2×PD-1 bispecific antibody, has the potential to be an effective treatment in microsatellite stable (MSS) colorectal cancerPlanned initiation of registrational program for INCA33890 in MSS colorectal cancer in 2026Maturing data for INCB161734, a KRAS G12D inhibitor, shows a favorable safety profile and evidence of clinical benefit in heavily pre-treated pancreatic ductal adenocarcinoma (PDAC) patientsIncyte will expand on the results from the oral presentations at an in-person and webcasted event on Sunday, October 19, 2025, from 1:30 – 3:00 p.m. EDT (7:30 – 9:00 p.m. CEST) Incyte (Nasdaq:INCY) announced the first clinical data evaluating its TGFβR2×PD-1 bispecific antibody (INCA33890) for patients with microsatellite stable (MSS) colorectal cancer; and its potent, selective and orally bioavailable KRAS G12D inhibitor (INCB161734) for patients with KRAS G12D mutations, specifically pancreatic ductal adenocarcinoma (PDAC). The data were
Corcept Presents ESMO 2025 Late-Breaker: Relacorilant Demonstrates Benefit in Patients with Platinum-Resistant Ovarian Cancer with Prior PARP Inhibitor Treatment19.10.2025 11:15:00 CEST | Press release
New data from pivotal Phase 3 ROSELLA trial reinforce relacorilant plus nab-paclitaxel improves progression-free and overall survival in patients with platinum-resistant ovarian cancer, with no need for biomarker selection – including in people who progressed while on or after taking a PARP inhibitor, a patient population with particularly poor prognosis Corcept expands BELLA trial to three study arms: (i) platinum-resistant ovarian cancer, (ii) platinum-sensitive ovarian cancer and (iii) endometrial cancer Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today shared new late-breaking data from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer at the European Society for Medical Oncology (ESMO) 2025 Annual
Deciphera Presents 2-Year Efficacy and Safety Results from MOTION Phase 3 Study of ROMVIMZA™ (vimseltinib) in Patients with Tenosynovial Giant Cell Tumor (TGCT) at the European Society for Medical Oncology Congress 202518.10.2025 13:00:00 CEST | Press release
– Vimseltinib demonstrated statistically significant and clinically meaningful benefit vs placebo in antitumor response – Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”), today announced the two-year efficacy and safety results from its MOTION Phase 3 study of vimseltinib in patients with TGCT in cases where surgical removal of the tumor is not an option will be presented as a poster during the 2025 European Society for Medical Oncology Congress (ESMO), taking place October 17-21 in Berlin, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251018921529/en/ “These long-term Phase 3 MOTION results add to the established body of evidence supporting vimseltinib as a best-in-class treatment for TGCT,” said Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera. “TGCT often causes debilitating pain, stiffness and impaired mobility and these results demonstrate the dura
ProAmpac Acquires International Paper’s Bag Converting Operations17.10.2025 16:09:00 CEST | Press release
ProAmpac, a global leader in flexible packaging and material science, has acquired the bag converting operations of International Paper (“IP”), a global leader in sustainable packaging. The acquisition expands ProAmpac’s converting capabilities, further advancing the company’s Fiberization of Packaging® strategy and enhancing its ability to deliver customized bag solutions for the grocery, convenience store, and quick-service restaurant markets. “Global demand for reliable, recyclable paper packaging continues to grow rapidly amid evolving consumer expectations and market trends redefining recyclability,” stated Greg Tucker, ProAmpac founder, vice chairman, and chief executive officer. “ProAmpac’s acquisition of IP’s bag operation supports our Fiberization of Packaging initiatives, helping us better serve customers by extending our expertise in material science to the US west coast with additional capabilities and redundancies,” continued Tucker. “IP’s bag business is strong, being bui
Pimicotinib Treatment Demonstrates Deep and Durable Tumor Responses and Continued Improvements in Pain and Function for Patients with TGCT17.10.2025 16:00:00 CEST | Press release
With median follow-up of 14.3 months, pimicotinib demonstrated increasing ORR over time, from 54% at Week 25 to 76.2%Global Phase 3 MANEUVER study demonstrated ongoing improvements in key secondary endpoints including pain and functionApplication for marketing authorization under review by China National Medical Products Administration (NMPA), with additional applications planned in the U.S. and other marketsNot intended for Canada-, UK- or US-based media Merck, a leading science and technology company, today announced the presentation of longer-term results from the global Phase 3 MANEUVER trial evaluating pimicotinib, an investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics Co., Ltd., for the treatment of patients with tenosynovial giant cell tumor (TGCT). This latest analysis showed that, with a median follow-up of 14.3 months, the objective response rate (ORR) for people treated with pimicotinib from the beginning of the stud
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom