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ELI LILLY AND COMPANY

(LLY)
  Report
Delayed Nyse  -  04:04 2022-09-23 pm EDT
311.46 USD   +0.19%
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FDA Approves Eli Lilly and Company's Retevmo (selpercatinib), the First and Only RET Inhibitor for Adults with Advanced or Metastatic Solid Tumors with a RET Gene Fusion, Regardless of Type

09/21/2022 | 07:12pm EDT

Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) has granted approval to Retevmo® (selpercatinib, 40 mg & 80 mg capsules) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on ORR and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

In addition to the tumor-agnostic approval, the FDA has granted traditional approval for Retevmo in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a RET gene fusion, as detected by an FDA-approved test. This FDA action broadens the Retevmo label to include patients with locally advanced disease and converts the May 2020 accelerated approval for NSCLC to a traditional approval. The labeling for Retevmo contains warnings and precautions for hepatotoxicity (evidence of liver dysfunction), interstitial lung disease (ILD)/pneumonitis, hypertension, QT interval prolongation, hemorrhagic events, hypersensitivity, tumor lysis syndrome, risk of impaired wound healing, hypothyroidism, and embryo-fetal toxicity.

The two approvals are supported by data from the pivotal LIBRETTO-001 trial, which is the larger clinical trial of patients with RET-driven cancers treated with a RET inhibitor. The multicenter, open-label, multi-cohort study enrolled patients with locally advanced or metastatic RET-driven solid tumors, including NSCLC. Major efficacy outcomes were ORR and DOR, assessed by a blinded independent review committee (BIRC).

Prespecified secondary endpoints included central nervous system (CNS) ORR and CNS DOR. Among the 41 patients in the tumor-agnostic data set, the most common cancers were pancreatic adenocarcinoma (27%), colorectal (24%), salivary (10%), and unknown primary (7%). Thirty-seven patients (90%) received prior systemic therapy (median 2 [range 0 – 9]; 32% received 3 or more).


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09/21FDA Approves Lilly's Retevmo« (selpercatinib), the First and Only RET Inhibitor for Adu..
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Financials (USD)
Sales 2022 28 869 M - -
Net income 2022 6 379 M - -
Net Debt 2022 10 150 M - -
P/E ratio 2022 45,2x
Yield 2022 1,23%
Capitalization 296 B 296 B -
EV / Sales 2022 10,6x
EV / Sales 2023 9,98x
Nbr of Employees 35 000
Free-Float 99,7%
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Number of Analysts 23
Last Close Price 311,46 $
Average target price 337,05 $
Spread / Average Target 8,22%
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Managers and Directors
David A. Ricks Chairman, President & Chief Executive Officer
Anat Ashkenazi Chief Financial Officer & Senior Vice President
Daniel M. Skovronsky Chief Scientific Officer & Senior Vice President
Diogo Rau Senior VP, Chief Information & Digital Officer
Alonzo Weems Senior VP, Chief Ethics & Compliance Officer
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