Lurbinectedin . Según Jason Niu , Oncólogo Torácico y Director del Programa de Cáncer de Pulmón en el Centro de Cáncer Banner MD Anderson , Espero que este Agente Sea Aprobado Pronto.
JESSICA HERGERT
Monday, March 16, 2020
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| Jiaxin ( Jason ) MD, PhD |
In the second-line setting, what developments have been made with Lurbinectedin?
Lurbinectedin is a very interesting compound. The first-generation agent trabectedin (Yondelis) is approved to treat patients with sarcoma, but lurbinectedin is more of a second-generation synthetic drug. As a result, lurbinectedin is a more potent and better-tolerated agent than trabectedin.
A phase I/Ib study looked at lurbinectedin alone and in combination with doxorubicin, and results showed a synergistic effect between the combined agents. As a result, a phase II basket trial enrolling patients with ovarian cancer, breast cancer, and SCLC was conducted. The results of the SCLC cohort were presented at the 2019 ASCO Annual Meeting.
The trial enrolled about 105 patients with platinum-sensitive and platinum-resistant SCLC. Both groups showed impressive responses. In particular, single-agent lurbinectedin demonstrated up to a 45% response rate and an 11-month median OS for patients with platinum-sensitive SCLC.
This agent is well tolerated. We mainly see hematologic toxicities, which are manageable from a medical oncology standpoint. As such, I fully expect this agent to be approved soon.
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Jazz Phamaceuticals en el Radar de los Accionistas que buscan empresas de Biotecnología a Precios de Ganga . Lurbinectedin could help the company decrease its top-line exposure to Xyrem.
Jazz's Pipeline Is Promising.
Jazz boasts several exciting products in its pipeline or that are currently being evaluated by health regulators.
First, the company submitted a New Drug Application (NDA) for JZP-258 to the U.S. Food and Drug Administration (FDA) in January. JZP-258 is a potential treatment for cataplexy and excessive daytime sleepiness (EDS) associated with narcolepsy.
Narcolepsy, a chronic sleep disorder that affects about one in 2,000 people in the U.S., is severely under-diagnosed: Up to 50% of those with this condition have not been diagnosed. Furthermore, narcolepsy is associated with other conditions, such as hypertension and cardiovascular disease. For those reasons, Jazz has high hopes for JZP-258.
Second, Jazz submitted an NDA to the FDA for Lurbinectedin for the treatment of relapsed small-cell lung cancer (SCLC). Lurbinectedin was granted a priority review by the FDA, which means the review process will be shorter than usual.
There are about 30,000 cases of SCLC in the U.S. per year. The company said: "There remains a critical unmet need for patients with relapsed SCLC, as the treatment landscape has not changed substantially in more than two decades since the last new chemical entity, topotecan, was approved." Jazz is expecting an answer from the FDA in mid-August, and if approved, Lurbinectedin could help the company decrease its top-line exposure to Xyrem.
First, the company submitted a New Drug Application (NDA) for JZP-258 to the U.S. Food and Drug Administration (FDA) in January. JZP-258 is a potential treatment for cataplexy and excessive daytime sleepiness (EDS) associated with narcolepsy.
Narcolepsy, a chronic sleep disorder that affects about one in 2,000 people in the U.S., is severely under-diagnosed: Up to 50% of those with this condition have not been diagnosed. Furthermore, narcolepsy is associated with other conditions, such as hypertension and cardiovascular disease. For those reasons, Jazz has high hopes for JZP-258.
There are about 30,000 cases of SCLC in the U.S. per year. The company said: "There remains a critical unmet need for patients with relapsed SCLC, as the treatment landscape has not changed substantially in more than two decades since the last new chemical entity, topotecan, was approved." Jazz is expecting an answer from the FDA in mid-August, and if approved, Lurbinectedin could help the company decrease its top-line exposure to Xyrem.
APLIDIN IL FARMACO DELLA SPERANZA.
Allora non se ne esce dal labirinto ecco perchè è fondamentale trovare nel vitro l’anticorpo universale che riesca a schiacciare il Covid-19.
In base ad una ricerca approfondita che arriva dalla Spagna e che dà buone speranze, il colosso farmaceutico PharmaMar avrebbe individuato nel APLIDIN, quel farmaco in grado di salvare molte vite umane. E’ composto a base di plitidepsina, spiegano i ricercatori, è ha superato positivamente il test in vitro per il coronavirus umano HCoV-229E, un patogeno con un meccanismo di moltiplicazione e propagazione molto simile a quello del Covid-19.
I suoi effetti – Quando il farmaco entra nel corpo si lega automaticamente a una proteina umana, essenziale per la malattia Sars-CoV-2 per diffondersi nel corpo. Aplidin potrebbe inibire la capacità di diffusione del virus e quindi la sua riproduzione.
Chiudo con la speranza che questa ricerca fondata, possa tornare a dare ossigeno ai polmoni del Mondo, perchè non esiste un angolo immune e la guerra la si vince, con le strategie che solo la medicina e la scienza sono in grado di scoprire.
In questo momento i cannoni possono rimanere senza le bombe.
In questo momento i cannoni possono rimanere senza le bombe.