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AstraZeneca’s Truqap plus Faslodex receives FDA approval for advanced breast cancer

AstraZeneca’s (AZ) AKT inhibitor Truqap (capivasertib) in combination with its endocrine therapy Faslodex (fulvestrant) has been approved by the US Food and Drug Administration (FDA) to treat a subset of advanced breast cancer patients. The FDA’s decision specifically applies to adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer with at least one of three biomarker alterations: PIK3CA, AKT1 or PTEN. The US regulator has also approved the use of a companion diagnostic test to detect the relevant alterations. Eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy. Breast cancer is the most common cancer worldwide and more than 290,000 people in the US are expected to be diagnosed with breast cancer in 2023. HR-positive breast cancer is the most common subtype, with over 65% of tumours considered HR-positive and HER2-low ...
- Source: drugdu
- 118
- November 21, 2023
China’s NMPA grants conditional approval for Apollomics’ NSCLC drug

The National Medical Products Administration (NMPA) of China granted conditional approval to biotech Apollomics for the commercialisation of its non-small cell lung cancer (NSCLC) treatment. Velbretinib (APL-101) is an orally bioavailable small molecule that treats NSCLC patients with MET exon 14 skipping alterations by inhibiting c-Met. This is a protein that is key in the tumour growth pathway. MET exon 14 skipping mutations occur in approximately 3% of cases of NSCLC. This condition is most diagnosed in adults aged over 70 with a smoking history. China’s NMPA grants conditional approvals to treatments for diseases that are severely life-threatening and there is no effective treatment method. Under the terms of an agreement, the company’s Chinese partner, Avistone, holds the drug’s exclusive rights in China, Hong Kong and Macau. Apollomics holds the rights for the US and all other countries. California-headquartered Apollomics is also in active discussions with the US Food and ...
- Source: drugdu
- 107
- November 21, 2023
CDC rushes extra doses of Sanofi, AZ’s Beyfortus to ease supply shortfall

In response to a supply squeeze for Sanofi and AstraZeneca’s respiratory syncytial virus (RSV) antibody Beyfortus, the U.S. Centers for Disease Control and Prevention (CDC) is fast-tracking tens of thousands of extra doses into circulation. More than 77,000 additional doses will be distributed “immediately” to physicians and hospitals through the CDC’s Vaccines for Children program and commercial routes, the agency said in a Thursday statement. Alongside the FDA, the CDC plans to maintain “close contact” with manufacturers to secure availability of extra supply through the end of this year and early 2024, the CDC added. The supply strain began last month despite Sanofi’s “aggressive” plan that was designed to “outperform past pediatric vaccine launches,” the company said at the time. The company said it was working with AstraZeneca to “explore a number of actions” to extend the manufacturing network. AZ handles manufacturing under the duo’s Beyfortus partnership. Sanofi previously noted ...
- Source: drugdu
- 139
- November 21, 2023
FDA signs off on new uses for Astellas and Pfizer’s Xtandi, Merck’s Keytruda

The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. Keytruda’s expansion is in stomach cancer, allowing its use alongside chemotherapy to treat first-line patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Xtandi’s new indication expands its already deep portfolio in the treatment of prostate cancer. It now becomes the only androgen receptor inhibitor approved by the FDA for patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). These patients can be treated with Xtandi with or without GnRH analog therapy. Of men who have had prostate cancer treatment, 20% to 40% will have BCR within 10 years. Of those with high-risk BCR, 90% will develop metastatic disease, with one in three dying. The nod was backed up by the phase 3 EMBARK ...
- Source: drugdu
- 117
- November 21, 2023
AstraZeneca Cancer Drug Is First in Class, But FDA Nod Is Narrower Than Expected

The most common type of breast cancer now has a new targeted treatment: an AstraZeneca drug that’s first in a new class of therapies addressing a certain genetic signature. But the new approval is narrower than expected, which limits the total addressable market for the therapy. The FDA approved the new drug, capivastertib, for use in combination with fulvestrant, an older AstraZeneca breast cancer therapy. The new drug will be marketed under the brand name Truqap. Approval of Truqap covers the treatment of adults with advanced cases of breast cancer classified as HR positive and HER2 negative. Those patients must also have disease that has either progressed after treatment with a hormone therapy or has come back after adjuvant therapy. Truqap joins a group of therapies already available for HR positive, HER2 negative breast cancer, including products from AstraZeneca. Truqap stands apart from them as the first AKT inhibitor. AKT ...
- Source: drugdu
- 117
- November 20, 2023
Benzodiazepine prescribing practices for homeless veterans with mental illness

What question were you investigating? Despite elevated risk for substance use disorder and overdose death in the homeless population, benzodiazepine prescribing for this population has not been examined. Our team therefore set out to answer the questions:  What is the rate of benzodiazepine prescribing to homeless vs. non-homeless veterans with mental illness in the VA system?  Are homeless veterans more likely to receive risky and potentially inappropriate prescriptions? What methods did you use? We used logistic regression to compare likelihood of benzodiazepine prescribing and tests to compare indicators of risky and potentially inappropriate benzodiazepine prescribing patterns for homeless veterans with mental illness and their housed counterparts. Our approach was unique in that it is the first study to attempt to investigate this question. We were able to do so in a large, national VA database, the country’s largest provider of homeless services. What did you find? We found ...
- Source: drugdu
- 118
- November 20, 2023
Inari Medical closes LimFlow acquisition

BY SEAN WHOOLEY The LimFlow System. [Illustration courtesy of LimFlow] Inari Medical (Nasdaq: NARI)+ announced that it completed its acquisition of chronic limb-threatening ischemia (CLTI) treatment maker LimFlow. The Irvine, California–based company earlier this month announced plans to acquire LimFlow for up to $415 million. The deal came just weeks after Paris-based LimFlow won FDA premarket approval (PMA) for its breakthrough CLTI treatment. Inari Medical intends to pay a total upfront consideration of $250 million in cash at closing. Contingent consideration of up to $165 million in additional cash payments hinges on certain commercial and reimbursement milestones. Inari Medical expects to pay those tranches out between 2025 and 2027. The company said it funded the acquisition at close from existing cash resources. LimFlow designed its system for transcatheter arterialization of deep veins. It diverts blood from a diseased tibial artery to a tibial vein to deliver oxygen to a patient’s ...
- Source: drugdu
- 105
- November 20, 2023
Q&A With Dr. Mike McCullar, CEO of RegCell

Mike Hollan McCullar discusses his new role as CEO of RegCell. Dr. Mike McCullar CEO RegCell Pharmaceutical Executive: How did you end up as CEO? Dr. Mike McCullar: Prior to joining RegCell as CEO and president, I was a toxicologist by training. I was fortunate to work in multiple operating roles over the years. I ended up working in Japan for a decade, and I was approached by a leading Japanese venture fund and asked if could help them start to migrate leading Japanese companies to the US. RegCell was one of those companies, and I felt it had the potential to have the best-in-class platform in terms of how we think about treating autoimmune disorders. It’s been an interesting journey so far. PE: What are the companies plans for the coming year? McCullar: What we’re focused on right now is launching a first in-human clinical trial. That takes quite ...
- Source: drugdu
- 117
- November 20, 2023
World’s first CRISPR-based gene therapy approved for sickle cell anaemia

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted conditional marketing authorisation to Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exagamglogene autotemcel), marking the world’s first approval of a CRISPR-based gene editing therapy. Casgevy has been approved to treat patients with sickle cell disease with recurrent vaso-occlusive crises and transfusion-dependent beta-thalassemia aged 12 years or older, for whom a human leukocyte antigen (HLA) matched related hematopoietic stem cell donor is not available. Also known as exa-cel, Casgevy is currently being evaluated by the US Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target action date for the drug is set for 8 December in severe sickle cell disease and 30 March 2024 in beta-thalassemia, as per a 16 November press release. Casgevy is a genetically modified autologous CD34+ cell population that contains clustered regularly interspaced short palindromic repeats (CRISPR) edited human haematopoietic stem and progenitor ...
- Source: drugdu
- 106
- November 20, 2023
BMS strengthens NSCLC market share with ROS1 drug Augtyro

The US Food and Drug Administration (FDA) has approved Bristol Myer Squibs’ (BMS) Augtyro (repotrectinib) for adults with non-small cell lung cancer (NSCLC). Augtyro is an orally administered tyrosine kinase inhibitor (TKI) designed to selectively bind to active kinase formations in ROS1-positive NSCLC and suppress uncontrolled cell proliferation and tumor growth caused by ROS1 oncogenic fusions. It is the only FDA-approved TKI for ROS1-positive NSCLC. The FDA approval was based on data from the ongoing Phase I/II TRIDENT-1 (NCT03093116) trial, which is evaluating repotrectinib in 500 patients with advanced solid tumours characterized by ALK, ROS1, or NTRK1-3 fusions. The Phase I portion assessed the safety, tolerability, and pharmacokinetics of repotrectinib. Patients previously treated with a TKI and no chemotherapy demonstrated an overall response rate (ORR) of 38% and a median DOR of 14.8 months. Patients with no prior treatment with a TKI had an ORR of 79% and a median ...
- Source: drugdu
- 104
- November 20, 2023

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