Chorco de los lobos

maiden666 escribió: ↑

06 Dic 2020 06:06

La plitidespsina evita la cascada inflamatoria que acaba con la vida de muchos pacientes afectados.

https://www.latribunadealbacete.es/noti ... anti-Covid

Himbersor escribió: ↑

06 Dic 2020 14:42

Point72 ya no está como corto en la cnmv

https://www.cnmv.es/Portal/Consultas/EE ... A-78267176

Assuming that data from the ongoing phase 2 study supports an accelerated approval under 21 CFR 314.500, Subpart H, PharmaMar proposes the ongoing phase 3 (ATLANTIS), open-label, randomized, clinical trial of lurbinectedin/doxorubicin versus CAV or topotecan in patients with SCLC who failed one prior platinum-containing line, as a confirmatory trial to support full approval. Does the Division agree?
FDA Response: FDA does not agree that the data from the SCLC cohort in Study PM1183-B-005-14 will support accelerated approval.
Regarding the ATLANTIS trial, FDA has continued concerns regarding its ability to support a marketing application for lurbinectedin, administered in combination with doxorubicin, because the trial is not adequate in design to isolate the individual contributions of lurbinectedin and of doxorubicin to the treatment effect observed with the combination.
Reference ID: 436622606516

IND 127944 Page 10
As previously stated by FDA during the January 28, 2016 meeting with PharmaMar, there is a potential to isolate the contribution of lurbinectedin when administered with doxorubicin through a comparison of a stratified subgroup randomized to CAV or lurbinectedin plus doxorubicin, provided that the magnitude of the treatment effect for lurbinectedin plus doxorubicin compared with CAV is clinically meaningful. FDA stated that it is essential to demonstrate that the addition of lurbinectedin contributes to the combination of lurbinectedin plus doxorubicin in order to determine if there is substantial evidence of effectiveness for lurbinectedin. In their assessment for substantial evidence of effectiveness, FDA would look at the totality of the data, including information from Phase 2 studies and other clinical information, but FDA will not place great reliance on the nonclinical data.
Based on the results reported for ORR and DoR in the cohort of patients with SCLC treated in Study PM1183-B-005-14, lurbinectedin as a single agent has clinical activity in SCLC that has progressed following platinum-based chemotherapy. Therefore, PharmaMar will also need to characterize the contribution of doxorubicin to the treatment effect observed with the combination of lurbinectedin and doxorubicin. This assessment should be based primarily on clinical data, since FDA will place minimal reliance on the nonclinical data
PharmaMar’s Response received via email on December 10, 2018: PharmaMar acknowledges the FDA concerns regarding the ATLANTIS trial, and understands that there is a potential to isolate the contribution of lurbinectedin when administered with doxorubicin through a comparison of a stratified subgroup randomized to CAV or lurbinectedin plus doxorubicin.
PharmaMar understands that ATLANTIS would be acceptable to support a marketing authorization provided that the magnitude of the treatment effect for lurbinectedin plus doxo compared with CAV is clinically meaningful. In this sense we would like to clarify that the ATLANTIS Protocol was amended and submitted to the Agency in May 2018. A new secondary objective was included in order to characterize the contribution of PM01183 to the PM01183/DOX combination in the stratum of patients with CAV as Investigator’s choice:
Secondary Objective:
Difference in OS between PM01183/DOX and CAV, in patients with CAV as best Investigator’s choice.
The analysis of the secondary endpoints will be performed using hierarchical methods and type I error correction for multiplicity (i.e. comparison with CAV and comparison in patients without baseline CNS).
In addition, a tertiary endpoint was included to assess the efficacy and safety profiles in the subgroups of the PM01183/DOX arm vs. CAV or topotecan.
Reference ID: 436622606516

IND 127944 Page 11
Tertiary Objectives:
Subgroup analyses of the PM01183/DOX arm vs. CAV based on investigator’s preference will be performed to isolate the contribution of PM01183 in the PM01183/DOX combination arm. Those for whom the investigator’s preference was topotecan, it will be also analyzed independently.