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Once-a-day Breast Cancer Tablet To Be Rolled Out On NHS

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Tevimbra By BeiGene For Triple-Negative Breast Cancer (TNBC): Likelihood Of Approval

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Tevimbra overview

Tislelizumab (Baizean, Tevimbra, Tizveni) is a humanized monoclonal antibody that belongs to a class of immuno-oncology agents. It is formulated as concentrated solution for infusion for intravenous route of administration. Baizean is used for the treatment of patients with classical Hodgkin's lymphoma (cHL) who have received at least two prior therapies and treatment for patients with locally advanced or metastatic urothelial carcinoma (UC). It is also indicated as a second- or third-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Baizean is indicated for the treatment of adult patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, including patients with advanced colorectal cancer (CRC) who had been treated with fluoropyrimidine, oxaliplatin and irinotecan and other advanced solid tumors who develop disease progression after prior treatment and have no satisfactory alternative treatment options. Baizean is indicated as a treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression or are intolerant to first-line standard chemotherapy. Tislelizumab, in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC). It is also indicated to treat cancers associated with homologous-recombination deficient (HRD).

Tislelizumab is under development for the treatment of locally advanced rectal cancer, hepatocellular carcinoma (HCC), glioblastoma multiforme (GBM), acute myelocytic leukemia, relapsed and refractory acute myeloid leukemia, primary mediastinal large B-cell lymphoma, triple negative breast cancer (TNBC), gallbladder cancer, pancreatic ductal adenocarcinoma, recurrent head and neck cancer squamous cell carcinoma, locally advanced or metastatic urothelial carcinoma, non-small cell lung cancer, esophageal squamous cell carcinoma, melanoma, metastatic esophageal, HER2 positive breast cancer, gastric, or gastroesophageal junction carcinoma (as a first line therapy), squamous non-small cell lung cancer, advanced solid tumors such as triple negative breast cancer, ovarian cancer, colorectal cancer, cervical cancer, pancreatic cancer, gastric cancer, hepatocellular carcinoma, non-squamous non-small cell lung cancer, sarcomas, cholangiocarcinoma, chronic lymphocytic leukemia (CLL), follicular lymphoma, aggressive lymphoma, including diffuse large B-cell lymphoma (DLBCL), renal cell carcinoma, squamous cell carcinoma, cutaneous squamous cell carcinoma, adrenocortical carcinoma, metastatic esophageal squamous cell carcinoma, urothelial carcinoma, mesothelioma, adenocarcinoma of mandible, undifferentiated adenocarcinoma from teratoma, blood borne cancer, metastatic hormone refractory (castration resistant, androgen-independent) prostate cancer, small-cell lung cancer,  metastatic adenocarcinoma of the pancreas, non-small cell lung cancer, T-cell lymphomas such as anaplastic T-cell lymphoma, Extranodal NK/T-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), relapsed or refractory classical Hodgkin lymphoma (cHL), gastrointestinal stromal tumor (GIST), mantle cell lymphoma, marginal zone B cell lymphoma, adenoid cystic carcinoma, nasopharyngeal cancer, renal pelvis cancer, ureter cancer, bladder cancer, nasopharyngeal cancer, oral cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, thymic carcinoma or urethral cancer. It is administered by intravenous drip route and subcutaneous route. The drug candidate is a highly selective and potent, humanized anti-PD-1 monoclonal antibody.

It was also under treatment for the treatment of duodenal cancer, anal squamous cell cancer, glioblastoma multiforme, non-muscle invasive bladder cancer (MIBC), Waldenstrom macroglobulinemia, ESCC, NSCLC,  high-risk myelodysplastic syndromes, adenocarcinoma of the gastroesophageal junction, RHNSCC, esophageal cancer ,TNBC, sezary syndrome, mycosis fungoides, GIST, HCC, angioimmunoblastic T-cell lymphoma (AITL)/immunoblastic lymphadenopathy, peripheral T-cell lymphomas (PTCL), natural killer cell lymphomas, anaplastic large cell lymphoma (ALCL), endometrial cancer, fallopian tube cancer, head and neck cancer squamous cell carcinoma, merkel cell carcinoma, metastatic adenocarcinoma of the pancreas, brain metastasis, metastatic castration-resistant prostate cancer (mCRPC), muscle invasive bladder cancer (MIBC), ovarian cancer, pancreatic cancer, peritoneal cancer, renal cell carcinoma, sarcomas, small-cell lung cancer, squamous cell carcinoma, thyroid cancer.

BeiGene overview

BeiGene is a biotechnology company. It specializes in the development and commercialization of immuno-oncology medicines to treat cancers. The company offers Zanubrutinib, a small molecule inhibitor to treat various blood cancers and Sonrotoclax, a small molecule Bcl-2 inhibitor for treating chronic lymphocytic leukemia. BeiGene also provides Tislelizumab (BGB-A317), a monoclonal antibody targeting solid tumors and hematologic cancer; and Pamiparib (BGB-290) against solid tumor malignancies. The company has operations in the US, Australia, Germany, Spain, Canada, Switzerland and Italy. BeiGene is headquartered in the Cayman Islands.

For a complete picture of Tevimbra's drug-specific PTSR and LoA scores, buy the report here.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData's Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData's Pharmaceutical Intelligence Center.


Black Women And The Side Effect They Often Face From Breast Cancer

Women undergoing chemotherapy for breast cancer often face many side effects. One, called neuropathy, can be extremely painful and research shows Black women are more likely to experience it.

Now, doctors are finding ways to decrease that risk.

Saysha Wright is a busy mother of two.

"I'm a football mom, a cheerleading mom," she said.

She's also a breast cancer survivor. In 2019, at just 31 years old…

"I found a lump," Wright recalled.

She had Stage 2 breast cancer. She started chemotherapy and after a couple of treatments, she developed neuropathy… a side effect that causes numbness, tingling, and pain in the hands and feet.

"I couldn't feel my fingertips or my toes. So when I would try to braid my baby's hair or button up my kids' clothes, I couldn't. I had no feeling whatsoever," she explained.

"Neuropathy is a tough side effect," said Dr. Bryan Schneider, a Vera Bradley Professor of Oncology at the IU Simon Comprehensive Cancer Center.

He said anyone can experience it during chemotherapy, but the risk is "substantially" higher in Black women.

"We've been on a decade-long mission to try to understand why that is," Schneider said.

He led a clinical study of Black women with breast cancer who were undergoing treatment to see if there was a way to reduce the risk of neuropathy.

"And what we found, fortunately, was that one of the drugs, a commonly used drug called Taxotere or Docetaxel, has significantly less neuropathy in this population," Schneider explained.

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Schneider said this is a huge step in improving treatment and life after treatment. Because for some women, once they develop neuropathy, it never goes away.

Fortunately, Wright recovered from her neuropathy, and she's four years into remission.

"Just fight. Don't give up," she encouraged others who face a breast cancer diagnosis.

Schneider said this drug can bring on many other side effects, so it requires an important conversation between the doctor and patient. But when the risk of neuropathy is high, preventing that usually trumps all the other side effects.

Copyright 2024 by Ivanhoe Newswire - All rights reserved.






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