Aromatic amines

Regulatory update from US Food and Drug Administration

Retrieved on: 
Wednesday, July 28, 2021

The Company has an ongoing dialogue with the FDA and will provide updated information as soon as more information becomes available.

Key Points: 
  • The Company has an ongoing dialogue with the FDA and will provide updated information as soon as more information becomes available.
  • The Company plans to submit complete data from the OCEAN-study to the International Myeloma Workshop meeting in Vienna on September 8-11, 2021.
  • The information was submitted for publication, through the agency of the contact persons above, on July 28, 2021, at 16:30 (CET).
  • They have all developed resistance to their last line of therapy, and within 18 months from the study start to lenalidomide, the most used drug in multiple myeloma.

Regulatory update from US Food and Drug Administration

Retrieved on: 
Wednesday, July 28, 2021

The Company has an ongoing dialogue with the FDA and will provide updated information as soon as more information becomes available.

Key Points: 
  • The Company has an ongoing dialogue with the FDA and will provide updated information as soon as more information becomes available.
  • The Company plans to submit complete data from the OCEAN-study to the International Myeloma Workshop meeting in Vienna on September 8-11, 2021.
  • The information was submitted for publication, through the agency of the contact persons above, on July 28, 2021, at 16:30 (CET).
  • They have all developed resistance to their last line of therapy, and within 18 months from the study start to lenalidomide, the most used drug in multiple myeloma.

FDA Approves Dose Escalation Label Update for Puma Biotechnology’s NERLYNX® (neratinib) in HER2-Positive Early Stage and Metastatic Breast Cancer

Retrieved on: 
Thursday, July 1, 2021

HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death.

Key Points: 
  • HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death.
  • Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care.
  • INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:
    As a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
  • Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.

Starton Therapeutics Advances STAR-LLD Transdermal Lenalidomide Following Successful Skin Permeation Studies

Retrieved on: 
Wednesday, June 9, 2021

With this milestone, Starton has advanced multiple formulation candidates in its transdermal lenalidomide (STAR-LLD) program into nonclinical studies.

Key Points: 
  • With this milestone, Starton has advanced multiple formulation candidates in its transdermal lenalidomide (STAR-LLD) program into nonclinical studies.
  • The invention includes a unique Method of Use with a pretreatment to modulate the outermost layer of the skin reversibly and facilitate drug uptake.
  • Using a 505(b)(2) approval path, Starton is not anticipating to have to repeat nonclinical safety studies.
  • Once target blood levels and skin tolerability are demonstrated, Starton will select a lead candidate to advance into human clinical trials.

Incyte and MorphoSys Announce Three-Year Results from Phase 2 L-MIND Study of Tafasitamab in Combination with Lenalidomide for the Treatment of Relapsed or Refractory DLBCL

Retrieved on: 
Friday, June 4, 2021

Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.

Key Points: 
  • Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
  • You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
  • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
  • Long-term analyses from L-MIND, a Phase II study of tafasitamab (MOR208) combined with lenalidomide (LEN) in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).

Puma Biotechnology Presents Data from the EGFR Exon 18-mutant NSCLC Cohort of the Phase II SUMMIT Trial at the 2021 ASCO Annual Meeting

Retrieved on: 
Friday, June 4, 2021

The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study that includes a cohort evaluating the safety and efficacy of neratinib administered daily to patients with EGFR exon 18-mutant non-small cell lung cancer (NSCLC).

Key Points: 
  • The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study that includes a cohort evaluating the safety and efficacy of neratinib administered daily to patients with EGFR exon 18-mutant non-small cell lung cancer (NSCLC).
  • A cohort of 11 patients with EGFR exon 18-mutant NSCLC from the Phase II SUMMIT basket trial, including patients with central nervous system involvement, were evaluated for safety and efficacy.
  • Prior lines of therapies included EGFR tyrosine kinase inhibitors (TKIs) (91%), chemotherapy (55%) and checkpoint inhibitors (IOs) (27%).
  • These results suggest that neratinib can be a potential treatment option for patients with NSCLC and hard-to-treat CNS metastases.

Puma Biotechnology Presents Data from the Phase III ExteNET Trial in Early Stage HER2-Positive Breast Cancer Patients at the Virtual 2021 ASCO Annual Meeting

Retrieved on: 
Friday, June 4, 2021

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented results from the Phase III ExteNET trial assessing the impact of neratinib treatment duration on overall survival (OS) in patients with early stage HER2-positive breast cancer at the virtual 2021 ASCO Annual Meeting.

Key Points: 
  • Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented results from the Phase III ExteNET trial assessing the impact of neratinib treatment duration on overall survival (OS) in patients with early stage HER2-positive breast cancer at the virtual 2021 ASCO Annual Meeting.
  • ExteNET was a multicenter, randomized, double-blind, Phase III trial of 2,840 HER2-positive early stage breast cancer patients who received neratinib after neoadjuvant and/or adjuvant therapy with chemotherapy and trastuzumab-based treatment.
  • These descriptive findings suggest that overall survival in patients with early stage HER2-positive breast cancer patients is improved upon completion of neratinib extended adjuvant therapy.
  • HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death.

Investigation Report on China's Lenalidomide Market 2021-2025 - ResearchAndMarkets.com

Retrieved on: 
Monday, May 10, 2021

b'The "Investigation Report on China\'s Lenalidomide Market 2021-2025" report has been added to ResearchAndMarkets.com\'s offering.\nLenalidomide is an oral immunomodulatory drug that is mainly used to treat blood cancers such as multiple myeloma, myelodysplastic syndrome, and lymphoma.

Key Points: 
  • b'The "Investigation Report on China\'s Lenalidomide Market 2021-2025" report has been added to ResearchAndMarkets.com\'s offering.\nLenalidomide is an oral immunomodulatory drug that is mainly used to treat blood cancers such as multiple myeloma, myelodysplastic syndrome, and lymphoma.
  • Celgene\'s Lenalidomide, REVLIMID was launched in China in 2013.
  • In addition to Celgene, the other manufacturers in the Chinese Lenalidomide market are Chia Tai Tianqing Pharmaceutical, Qilu Pharmaceutical, and Beijing SL Pharmaceutical.\nSales revenue of Lenalidomide in the Chinese market has an increasing trend from 2016 to 2020.
  • Especially after Lenalidomide was included in the national medical insurance catalog in the second half of 2017, the annual growth rate in 2018 reached 547.4%.

Tiziana Announces Strategic Initiative with Takanawa Japan K.K., Pharma Team, to Identify a Partner in Japan and Other Asian Countries for Further Clinical Development of Milciclib in Patients with Advanced Hepatocellular Carcinoma.

Retrieved on: 
Wednesday, May 5, 2021

The clinical data, presented at the American Society of Clinical Oncology (ASCO)1, demonstrated that the treatment was well-tolerated and produced clinical activity.

Key Points: 
  • The clinical data, presented at the American Society of Clinical Oncology (ASCO)1, demonstrated that the treatment was well-tolerated and produced clinical activity.
  • Recently, a patent covering the use of Milciclib in combination with a tyrosine kinase inhibitor (TKI) or other drugs was granted2.
  • The granted claims provide complete freedom to further develop a combination of Milciclib with an approved TKI for treatment of patients with advanced HCC or other cancers.
  • Takanawa also supports companies entering the Japanese and Asian market as well as Japanese companies to enter overseas markets.

Study: Older Multiple Myeloma Patients can be Spared of Long-Term Steroids

Retrieved on: 
Friday, March 19, 2021

WASHINGTON, March 19, 2021 /PRNewswire/ --The combination of cancer therapy lenalidomide plus the steroid dexamethasone (together called Rd) is considered standard treatment for elderly patients with multiple myeloma.

Key Points: 
  • WASHINGTON, March 19, 2021 /PRNewswire/ --The combination of cancer therapy lenalidomide plus the steroid dexamethasone (together called Rd) is considered standard treatment for elderly patients with multiple myeloma.
  • Multiple myeloma, a cancer affecting the blood plasma cells (a type of white blood cell in the bone marrow), most commonly occurs in people over 60.
  • This phase III clinical trial involved 33 medical centers in Italy and is the first to evaluate an adapted Rd treatment schedule that spares steroid use in older patients.
  • Nowadays, multiple myeloma patients usually receive continuous treatment including steroids, which are typically given until a patient's disease progresses or they are unable to tolerate the therapy, according to Dr. Larocca.