AstraZeneca and Daiichi Sankyo Receive CHMP’s Positive Opinion for Datroway to Treat HR+/HER2- Breast Cancer

Shots: The CHMP has recommended Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in pts receiving endocrine-based therapy & CT. Ongoing regulatory review in China & other regions Opinion was supported by a global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D) vs single agent…

ByDipanshu DixitFebruary 3, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (January 27, 2025 – January 31, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & DigiHealth. Check out our full report below: Merck and Eisai Reveal Latest Data from P-III (LEAP-015) Trial of Keytruda (pembrolizumab) and Lenvima (lenvatinib) Regimen to Treat Gastroesophageal Adenocarcinoma Read More: Merck and Eisai Novo Nordisk Completes P-Ib/IIa Study…

BySenior EditorJanuary 31, 2025

NEWS

Sanofi Receives China’s NMPA Approval for Sarclisa + SoC VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: China’s NMPA has approved Sarclisa with SoC VRd (bortezomib, lenalidomide, & dexamethasone) to treat ASCT-ineligible NDMM pts based on data showing improved PFS in P-III (IMROZ) trial; ongoing regulatory review in Japan for HSCT- ineligible NDMM pts This was preceded by NMPA approval of Sarclisa + pomalidomide & dexamethasone (Pd) for R/R MM pts who received ~1L…

ByDipanshu DixitJanuary 31, 2025

NEWS

ViiV Healthcare Reports the EC’s Approval of Vocabria + Rekambys to Treat HIV

Shots: ViiV Healthcare (owned by GSK with Pfizer & Shionogi as shareholders) has received EC’s approval for Vocabria (cabotegravir) combined with J&J’s Rekambys (rilpivirine) to treat HIV-1 in virologically suppressed adolescents (≥12yrs. & ≥35kg), following CHMP opinion in Dec 2024 MAA was based on 24wks. data from ongoing P-I/II (MOCHA) trial evaluating the safety,…

ByDipanshu DixitJanuary 31, 2025

NEWS

Axsome Therapeutics Receives the US FDA Approval for Symbravo (meloxicam and rizatriptan) to Treat Migraine

Shots: The US FDA has approved Symbravo for acute treatment of migraine with/without aura in adults based on P-III (MOMENTUM), P-III (INTERCEPT) & P-III (MOVEMENT) trial; commercially available in ~4mons. MOMENTUM trial assessed Symbravo (single dose) vs PBO/meloxicam/rizatriptan, showing greater pain & symptoms freedom (photophobia, phonophobia & nausea) at 2hrs., sustained through 24-48hrs., 77%…

ByDipanshu DixitJanuary 31, 2025

NEWS

Scholar Rock Reports the US FDA’s BLA Submission for Apitegromab to Treat Spinal Muscular Atrophy (SMA)

Shots: The US FDA received BLA, plus a request for a priority review of apitegromab to improve motor function in pts with SMA who are on SMN-targeted therapy. The EMA’s MAA to be filed in Q1’25 The BLA was supported by the P-III (SAPPHIRE) & P-II (TOPAZ) trial, where SAPPHIRE met its 1EP of…

ByDipanshu DixitJanuary 30, 2025

NEWS

Vertex Receives the US FDA Approval for Journavx (Suzetrigine) to Treat Acute Pain

Shots: The FDA has approved Journavx (50mg; BID) to treat moderate-to-severe acute pain in adults JOURNAVX is an oral, non-opioid pain signal inhibitor that selectively targets NaV1.8 relative to other NaV channels The company is also testing suzetrigine for peripheral neuropathic pain (PNP), with ongoing P-III trial for diabetic neuropathy and plans for…

ByDipanshu DixitJanuary 30, 2025

NEWS

Amgen Receives EC’s Approval for Blincyto to Treat Philadelphia Chromosome-Negative CD19-Positive B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)

Shots: The EC has approved Blincyto monotherapy as a part of consolidation therapy to treat 1L philadelphia chromosome-negative CD19+ B-ALL adults based on P-III (E1910) trial Blincyto + CT showed improved OS with 4.5yrs. median follow up vs CT alone, whereas 5-yrs. mFU demonstrated 82.4% vs 62.5% OS in 112 pts The trial was led by…

ByDipanshu DixitJanuary 30, 2025

NEWS

The EMA Accepts MAA for ImmunityBio’s Anktiva to Treat BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

Shots: The EMA has accepted MAA of Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS, & with/without papillary tumors, based on an ongoing QUILT 3.032 study. Application covers 27 EU countries, plus Iceland, Norway & Liechtenstein, with submission also made to the UK's MHRA As of the data cut-off on Jul…

ByDipanshu DixitJanuary 29, 2025

NEWS

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP

Shots: The EMA accepted depemokimab’s MAA as an add-on maintenance therapy for inadequately controlled asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively. NDA is also accepted by the NMPA & MHLW SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed…

BySenior EditorJanuary 28, 2025

AstraZeneca and Daiichi Sankyo Receive CHMP’s Positive Opinion for Datroway to Treat HR+/HER2- Breast Cancer

PharmaShots Weekly Snapshots (January 27, 2025 – January 31, 2025)

Sanofi Receives China’s NMPA Approval for Sarclisa + SoC VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

ViiV Healthcare Reports the EC’s Approval of Vocabria + Rekambys to Treat HIV

Axsome Therapeutics Receives the US FDA Approval for Symbravo (meloxicam and rizatriptan) to Treat Migraine

Scholar Rock Reports the US FDA’s BLA Submission for Apitegromab to Treat Spinal Muscular Atrophy (SMA)

Vertex Receives the US FDA Approval for Journavx (Suzetrigine) to Treat Acute Pain

Amgen Receives EC’s Approval for Blincyto to Treat Philadelphia Chromosome-Negative CD19-Positive B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)

The EMA Accepts MAA for ImmunityBio’s Anktiva to Treat BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP

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